EPA (Environmental Protection Agency)
1 records
fda
549 records
FDA Recall: Customed, Inc — Class II
20160420
Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution a | Product: Catalog Number: 9003190 SURG GOWN SM...
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FDA Recall: Customed, Inc — Class II
20160420
Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution a | Product: Catalog Number: 9002615 EXTREMITY SU...
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FDA Recall: Customed, Inc — Class II
20160420
Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution a | Product: Catalog Number: 9001482 ENT SURGICAL...
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FDA Recall: Customed, Inc — Class II
20160420
Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution a | Product: Catalog Number: 900110 TRACHEOSTOMY C...
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FDA Recall: Customed, Inc — Class II
20160420
Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution a | Product: Catalog Number: 9001408 UMBILICAL VE...
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FDA Recall: Customed, Inc — Class II
20160420
Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution a | Product: Catalog Number: 900582 UTILITY DRAPE...
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FDA Recall: Customed, Inc — Class II
20160420
Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution a | Product: Catalog Number: 900946 STRABISMUS SU...
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FDA Recall: Customed, Inc — Class II
20160420
Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution a | Product: Catalog Number: 9002830 ORTHOPEDIC S...
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FDA Recall: Customed, Inc — Class II
20160420
Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution a | Product: Catalog Number: 900921A C-SECTION SU...
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FDA Recall: Customed, Inc — Class II
20160420
Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution a | Product: Catalog Number: 9001538 DRESSING CHA...
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FDA Recall: Customed, Inc — Class II
20160420
Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution a | Product: Catalog Number: 900036 LAPAROTOMY SUR...
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FDA Device Recall: Catalog Number: 9003190 SURG GOWN SMS AMMI IV FULL Used by medical staff to p
2016-04-20
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
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FDA Device Recall: Catalog Number: 9002615 EXTREMITY SURGICAL PACK Used by medical staff to perf
2016-04-20
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
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FDA Device Recall: Catalog Number: 9001482 ENT SURGICAL PACK Used by medical staff to perform s
2016-04-20
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
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FDA Device Recall: Catalog Number: 900110 TRACHEOSTOMY CARE KIT WITH TRACH TUBE HOLDER FOR ADULT
2016-04-20
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
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FDA Device Recall: Catalog Number: 9001408 UMBILICAL VESSEL CATHETER KIT Used by medical staff
2016-04-20
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
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FDA Device Recall: Catalog Number: 900582 UTILITY DRAPE WITH TAPE, SMS Used by medical staff to
2016-04-20
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
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FDA Device Recall: Catalog Number: 900946 STRABISMUS SURGICAL PACK Used by medical staff to perf
2016-04-20
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
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FDA Device Recall: Catalog Number: 9002830 ORTHOPEDIC SURGICAL PACK Used by medical staff to per
2016-04-20
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
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FDA Device Recall: Catalog Number: 900921A C-SECTION SURGICAL PACK Used by medical staff to perf
2016-04-20
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
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FDA Device Recall: Catalog Number: 9001538 DRESSING CHANGE TRAY Used by medical staff to perform
2016-04-20
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
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FDA Device Recall: Catalog Number: 900036 LAPAROTOMY SURGICAL PACK Used by medical staff to perf
2016-04-20
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
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FDA Device Recall: Catalog Number: 900522 SURGICAL GOWN SMS POLY-REINFORCED, RAGLAN SLEEVE, AAMI
2016-04-20
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
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FDA Device Recall: Catalog Number: 900576A LAP-CHOLECYSTECTOMY SURGICAL PACK Used by medical st
2016-04-20
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
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FDA Device Recall: Catalog Number: 900028 LAPAROSCOPY SURGICAL PACK
2016-04-20
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
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FDA Device Recall: Catalog Number: 9002618 OPEN HEART SURGICAL PACK Used by medical staff to pe
2016-04-20
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
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FDA Device Recall: Catalog Number: 900345 BASIC SURGICAL PACK Used by medical staff to perform s
2016-04-20
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
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FDA Device Recall: Catalog Number: 9002726 HIP AND KNEE REPLACEMENT SURGICAL PACK Used by medic
2016-04-20
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
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FDA Device Recall: Catalog Number: 9002609 ARTHOSCOPY PACK Used by medical staff to perform sur
2016-04-20
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
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FDA Device Recall: Catalog Number: 900020 IRRIGATION TRAY WITH IRRIGATION BULB SYRINGE Used by me
2016-04-20
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
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FDA Device Recall: Catalog Number: 900782 SKIN STAPLE REMOVER STERILE Used by medical staff to p
2016-04-20
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
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FDA Device Recall: Catalog Number: 9001780 OPHTHALMIC SURGICAL PACK Used by medical staff to pe
2016-04-20
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
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FDA Device Recall: Catalog Number: 9002516 LAPAROTOMY SURGICAL PACK Used by medical staff to pe
2016-04-20
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
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FDA Device Recall: Catalog Number: 9002167 LITHOTOMY SURGICAL PACK Used by medical staff to per
2016-04-20
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
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FDA Device Recall: Catalog Number: 9001091 PERY-GYN SURGICAL PACK Used by medical staff to perfor
2016-04-20
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
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FDA Device Recall: Catalog Number: 9001456 WOUND MANAGEMENT TRAY Used by medical staff to perfor
2016-04-20
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
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FDA Device Recall: Catalog Number: 9001139 FOLEY CATHETER TRAY 18 FR -5CC-2WAY SILICONE COATED FOL
2016-04-20
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
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FDA Device Recall: Catalog Number: 900063 WOUND CLOSURE TRAY I Used by medical staff to perform s
2016-04-20
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
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FDA Device Recall: Catalog Number: 9001771 MAYO STAND COVER STERILE Used by medical staff to perf
2016-04-20
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
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FDA Device Recall: Catalog Number: 9001521 UROLOGY SURGICAL PACK Used by medical staff to perfo
2016-04-20
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
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FDA Device Recall: Catalog Number: 900540 WOUND MANAGEMENT TRAY III Used by medical staff to per
2016-04-20
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
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FDA Device Recall: Catalog Number: 900774 INCISION AND DRAINAGE TRAY Used by medical staff to pe
2016-04-20
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
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FDA Device Recall: Catalog Number: 900012 OB SURGICAL PACK Used by medical staff to perform surg
2016-04-20
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
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FDA Device Recall: Catalog Number: 9001127 FOLEY CATHETER TRAY 16 FR-5CC- 2WAY SILICONE COATED FOL
2016-04-20
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
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FDA Device Recall: Catalog Number: 900410 CESAREAN SECTION SURGICAL PACK Used by medical staff t
2016-04-20
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
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FDA Device Recall: Catalog Number: 9001771 MAYO STAND COVER STERILE Used by medical staff to per
2016-04-20
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
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FDA Device Recall: Catalog Number: 9002899 CYSTO TUR SURGICAL PACK Used by medical staff to per
2016-04-20
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
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FDA Device Recall: Catalog Number: 900740A ARTHROSCOPY SURGICAL PACK Used by medical staff to pe
2016-04-20
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
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FDA Device Recall: Catalog Number: 900982 ARTHROSCOPY SURGICAL PACK Used by medical staff to per
2016-04-20
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
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FDA Device Recall: Catalog Number: 9001202 LAMINECTOMY PK Used by medical staff to perform surgi
2016-04-20
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
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FDA Device Recall: Catalog Number: 900032 UNIVERSAL DRAINAGE TRAY Used by medical staff to perfor
2016-04-20
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
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FDA Device Recall: Catalog Number: 900486 LAPAROSCOPY SURGICAL PACK Used by medical staff to pe
2016-04-20
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
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FDA Device Recall: Catalog Number: 9002259A LAPAROSCOPY-COLORECTAL SURGICAL PACK Used by medical
2016-04-20
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
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FDA Device Recall: Catalog Number: 900176 LAPAROTOMY SURGICAL PACK Used by medical staff to perf
2016-04-20
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
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FDA Device Recall: Catalog Number: 9001294 PREMIUM CESAREAN PACK Used by medical staff to perfor
2016-04-20
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
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FDA Device Recall: Catalog Number: 900996 LAPAROTOMY SURGICAL PACK Used by medical staff to per
2016-04-20
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
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FDA Device Recall: Catalog Number: 9002224 SURGICAL PACK Used by medical staff to perform surgi
2016-04-20
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
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FDA Device Recall: Catalog Number: 9001061 PERI-GYN SURGICAL PACK Used by medical staff to perfor
2016-04-20
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
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FDA Device Recall: Catalog Number: 9001297 PREMIUM OBSTETRICAL SURGICAL PACK Used by medical sta
2016-04-20
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
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FDA Device Recall: Catalog Number: 900484 LAPAROSCOPIC GYNECOLOGY SURGICAL PACK Used by medical
2016-04-20
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
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FDA Device Recall: Catalog Number: 9002256 NEUROSURGERY PACK Used by medical staff to perform s
2016-04-20
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
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FDA Device Recall: Catalog Number: 900281A LAPAROTOMY PACK Used by medical staff to perform surg
2016-04-20
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
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FDA Device Recall: Catalog Number: 900521 SURGICAL GOWN SMS POLY-REINFORCED, RAGLAN SLEEVE, AAMI
2016-04-20
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
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FDA Device Recall: Catalog Number: 9001765 MINOR LACERATION TRAY Used by medical staff to perfor
2016-04-20
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
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FDA Device Recall: Catalog Number: 9001300 NEURO-SPINE SURGICAL PACK Used by medical staff to p
2016-04-20
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
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FDA Device Recall: Catalog Number: 900052 MINOR PROCEDURE SURGICAL PACK Used by medical staff to
2016-04-20
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
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FDA Device Recall: Catalog Number: 900474 LAPAROSCOPY SURGICAL PACK Used by medical staff to per
2016-04-20
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
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FDA Device Recall: Catalog Number: 9001496 D&C LAPAROSCOPY SURGICAL PACK Used by medical staff t
2016-04-20
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
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FDA Device Recall: Catalog Number: 900998 CESAREAN SECTION SURGICAL PACK Used by medical staff
2016-04-20
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
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FDA Device Recall: Catalog Number: 9002123 KNEE ARTHROSCOPY SURGICAL PACK Used by medical staff
2016-04-20
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
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FDA Device Recall: Catalog Number: 9001966 LIVER & PANCREAS SURGERY Used by medical staff to pe
2016-04-20
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
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FDA Device Recall: Catalog Number: 9001062 ARTHROSCOPY SURGICAL PACK Used by medical staff to pe
2016-04-20
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
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FDA Device Recall: Catalog Number: 900080 CYSTOSCOPY SURGICAL PACK Used by medical staff to perfo
2016-04-20
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
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FDA Device Recall: Catalog Number: 9002829 BASIC SURG PACK Used by medical staff to perform sur
2016-04-20
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
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FDA Device Recall: Catalog Number: 9002766 SHOULDER PACK Used by medical staff to perform surgic
2016-04-20
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
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FDA Device Recall: Catalog Number: 9001460 REYITO PLUS UROLOGY SURGICAL PACK Used by medical st
2016-04-20
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
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FDA Device Recall: Catalog Number: 900997 PERI-GYN SURGICAL PACK Used by medical staff to perfo
2016-04-20
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
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FDA Device Recall: Catalog Number: 9001298 PREMIUM ARTHROSCOPY PACK Used by medical staff to per
2016-04-20
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
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FDA Recall: Customed, Inc — Class II
20150909
Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution a | Product: LABOR & DELIVERY 4/CS Used by medi...
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FDA Recall: Customed, Inc — Class II
20150909
Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution a | Product: MINOR PACK 4/CS Used by medical sta...
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FDA Recall: Customed, Inc — Class II
20150909
Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution a | Product: GENERAL MINOR PK 5/CS Used by medical...
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FDA Recall: Customed, Inc — Class II
20150909
Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution a | Product: PREMIUM ARTHROSCOPY PK CUSTOMED 5/CS ...
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FDA Recall: Customed, Inc — Class II
20150909
Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution a | Product: MINOR LACERATION TRAY CUSTOMED 50/CS ...
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FDA Recall: Customed, Inc — Class II
20150909
Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution a | Product: UROLOGY PACK 4/CS Used by medical s...
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FDA Recall: Customed, Inc — Class II
20150909
Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution a | Product: SURG GOWN POLYREINF LGE CUSTOM 28/CS ...
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FDA Recall: Customed, Inc — Class II
20150909
Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution a | Product: WOUND MANAGEMENT CUSTOMED 20/CS Used...
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FDA Recall: Customed, Inc — Class II
20150909
Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution a | Product: EXTREMITY ARM PACK 4/CS HOSP. DR. CEN...
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FDA Recall: Customed, Inc — Class II
20150909
Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution a | Product: WOUND CLOSURE TRAY I CUSTOMED 50/CS ...
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FDA Recall: Customed, Inc — Class II
20150909
Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution a | Product: GAUZE SPONGE 2"X2" 8PLY COTTON 1500PK/...
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FDA Recall: Customed, Inc — Class II
20150909
Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution a | Product: LAPAROSCOPY PACK 6/CS Used by medical...
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FDA Recall: Customed, Inc — Class II
20150909
Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution a | Product: LABOR & DELIVERY 4/CS Used by medical...
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FDA Recall: Customed, Inc — Class II
20150909
Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution a | Product: Gown, surgical 30/CS Used by medic...
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FDA Recall: Customed, Inc — Class II
20150909
Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution a | Product: CESAREAN PACK 3/CS Used by medical ...
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FDA Recall: Customed, Inc — Class II
20150909
Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution a | Product: PERI GYN PACK 5/CS Used by medica...
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FDA Recall: Customed, Inc — Class II
20150909
Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution a | Product: PERY GYN PACK CUSTOMED 10/CS Used b...
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FDA Recall: Customed, Inc — Class II
20150909
Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution a | Product: ORTHO-IMPLANT SURGICAL PACK, Use...
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FDA Recall: Customed, Inc — Class II
20150909
Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution a | Product: LAPAROTOMY PACK 4/CS Used by medical...
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FDA Recall: Customed, Inc — Class II
20150909
Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution a | Product: WOUND CLOSURE TRAY II CUSTOMED 50/CS ...
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FDA Recall: Customed, Inc — Class II
20150909
Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution a | Product: HAIR RESTORATION PACK-THR 12/CS Us...
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FDA Device Recall: LABOR & DELIVERY 4/CS Used by medical staff to perform surgical procedures a
2015-09-09
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
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FDA Device Recall: MINOR PACK 4/CS Used by medical staff to perform surgical procedures and pat
2015-09-09
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
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FDA Device Recall: GENERAL MINOR PK 5/CS Used by medical staff to perform surgical procedures and
2015-09-09
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
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FDA Device Recall: PREMIUM ARTHROSCOPY PK CUSTOMED 5/CS Used by medical staff to perform surgic
2015-09-09
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
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FDA Device Recall: MINOR LACERATION TRAY CUSTOMED 50/CS Used by medical staff to perform surgi
2015-09-09
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
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FDA Device Recall: UROLOGY PACK 4/CS Used by medical staff to perform surgical procedures and p
2015-09-09
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
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FDA Device Recall: SURG GOWN POLYREINF LGE CUSTOM 28/CS Used by medical staff to perform surgi
2015-09-09
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
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FDA Device Recall: WOUND MANAGEMENT CUSTOMED 20/CS Used by medical staff to perform surgical proc
2015-09-09
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
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FDA Device Recall: EXTREMITY ARM PACK 4/CS HOSP. DR. CENTER Used by medical staff to perform surg
2015-09-09
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
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FDA Device Recall: WOUND CLOSURE TRAY I CUSTOMED 50/CS Used by medical staff to perform surgical
2015-09-09
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
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FDA Device Recall: GAUZE SPONGE 2"X2" 8PLY COTTON 1500PK/CS Used by medical staff to perform surg
2015-09-09
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
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FDA Device Recall: LAPAROSCOPY PACK 6/CS Used by medical staff to perform surgical procedures and
2015-09-09
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
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FDA Device Recall: LABOR & DELIVERY 4/CS Used by medical staff to perform surgical procedures and
2015-09-09
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
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FDA Device Recall: Gown, surgical 30/CS Used by medical staff to perform surgical procedures an
2015-09-09
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
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FDA Device Recall: CESAREAN PACK 3/CS Used by medical staff to perform surgical procedures and
2015-09-09
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
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FDA Device Recall: PERI GYN PACK 5/CS Used by medical staff to perform surgical procedures and
2015-09-09
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
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FDA Device Recall: PERY GYN PACK CUSTOMED 10/CS Used by medical staff to perform surgical proced
2015-09-09
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
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FDA Device Recall: ORTHO-IMPLANT SURGICAL PACK, Used by medical staff to perform surgical pro
2015-09-09
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
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FDA Device Recall: LAPAROTOMY PACK 4/CS Used by medical staff to perform surgical procedures and
2015-09-09
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
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FDA Device Recall: WOUND CLOSURE TRAY II CUSTOMED 50/CS Used by medical staff to perform surgica
2015-09-09
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
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FDA Device Recall: HAIR RESTORATION PACK-THR 12/CS Used by medical staff to perform surgical pr
2015-09-09
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
View Source
FDA Device Recall: LAPAROSCOPY PK 3/CS Used by medical staff to perform surgical procedures
2015-09-09
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
View Source
FDA Device Recall: LAPAROSCOPY-COLORECTAL SURGICAL PACK 2/CS Used by medical staff to perform su
2015-09-09
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
View Source
FDA Device Recall: PERY-GYN SURGICAL PACK 6/CS Used by medical staff to perform surgical procedu
2015-09-09
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
View Source
FDA Device Recall: PERI GYN PACK 10/CS Used by medical staff to perform surgical procedures and
2015-09-09
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
View Source
FDA Device Recall: GOWN COOL IMPEV. XLGE BREATHABLE 24/CS CUSTOMED Used by medical staff to perf
2015-09-09
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
View Source
FDA Device Recall: O.B. PACK HOSPITAL 3/CS Used by medical staff to perform surgical procedures an
2015-09-09
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
View Source
FDA Device Recall: ANGIODRAPE PACK DAMAS 6/CS Used by medical staff to perform surgical procedu
2015-09-09
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
View Source
FDA Device Recall: UROLOGY PACK 5/CS Used by medical staff to perform surgical procedures and pat
2015-09-09
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
View Source
FDA Device Recall: LITHOTOMY PACK 10/CS Used by medical staff to perform surgical procedures and
2015-09-09
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
View Source
FDA Device Recall: UTILITY DRAPE END PRODUCT 50PK/CS Used by medical staff to perform surgical pro
2015-09-09
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
View Source
FDA Device Recall: LAP-CHOLECYSTECTOMY SURGICAL PACK Used by medical staff to perform surgical pr
2015-09-09
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
View Source
FDA Device Recall: PREMIUM CESAREAN PACK CUSTOMED 5/CS Used by medical staff to perform surgical
2015-09-09
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
View Source
FDA Device Recall: SUTURE REMOVAL KIT CUSTOMED 100/CS Used by medical staff to perform patient ca
2015-09-09
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
View Source
FDA Device Recall: SUCTION CATHETER KIT CUSTOMED 50/CS Used by medical staff to perform surgica
2015-09-09
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
View Source
FDA Device Recall: TRACHEOTOMY CARE KIT CUSTOMED 50/CS Used by medical staff to perform surgical
2015-09-09
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
View Source
FDA Device Recall: GOWN SURG. POLY REINF. XL XLONG 40/CS CUSTOMED Used by medical staff to perf
2015-09-09
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
View Source
FDA Device Recall: OPEN HEART TRAY CUSTOMED 1/CS Used by medical staff to perform surgical pro
2015-09-09
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
View Source
FDA Device Recall: (1) (2) 10/CS CUSTOMED Used by medical staff to perform surgical procedures
2015-09-09
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
View Source
FDA Device Recall: UMBILICAL VESSEL CATHETER KIT CUSTOMED 8/CS Used by medical staff to perform
2015-09-09
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
View Source
FDA Device Recall: LAPAROSC. OB GYN PK 5/CS Used by medical staff to perform surgical pro
2015-09-09
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
View Source
FDA Device Recall: LUMBAR PACK 4/CS Used by medical staff to perform surgical procedures and
2015-09-09
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
View Source
FDA Device Recall: FACE PACK MRT 8/CS CUSTOMED Used by medical staff to perform surgical proced
2015-09-09
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
View Source
FDA Device Recall: CENTRAL LINE FULL BODY DRAPE CUSTOMED 28/CS Used by medical staff to perform s
2015-09-09
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
View Source
FDA Device Recall: EAR PACK 3/CS Used by medical staff to perform surgical procedures and patien
2015-09-09
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
View Source
FDA Device Recall: ARTHROSCOPY SURGICAL PACK 4/C Used by medical staff to perform surgical pr
2015-09-09
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
View Source
FDA Device Recall: BREAST PACK-TPSC 3/CS Used by medical staff to perform surgical procedures
2015-09-09
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
View Source
FDA Device Recall: ARTHROSCOPY PACK 3/Cs Used by medical staff to perform surgical procedures and
2015-09-09
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
View Source
FDA Device Recall: C-SECTION PK 2/CS Used by medical staff to perform surgical procedures and
2015-09-09
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
View Source
FDA Device Recall: OPEN HEART TRAY 1/CS Used by medical staff to perform surgical procedures an
2015-09-09
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
View Source
FDA Device Recall: FACE PACK FJG 8/CS Used by medical staff to perform surgical procedures and p
2015-09-09
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
View Source
FDA Device Recall: SHOULDER PACK 3/CS Used by medical staff to perform surgical procedures and
2015-09-09
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
View Source
FDA Device Recall: EAR PACK 3/CS Used by medical staff to perform surgical procedures and pa
2015-09-09
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
View Source
FDA Device Recall: PEDIATRIC LAP PACK 8/CS Used by medical staff to perform surgical procedures
2015-09-09
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
View Source
FDA Device Recall: LAPAROTOMY PACK CS/6 Used by medical staff to perform surgical procedures
2015-09-09
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
View Source
FDA Device Recall: OB PACK CS/4 Used by medical staff to perform surgical procedures and patien
2015-09-09
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
View Source
FDA Device Recall: E.N.T. PK 7/CS Used by medical staff to perform surgical procedures and pat
2015-09-09
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
View Source
FDA Device Recall: FEMORAL PACK 4/CS Used by medical staff to perform surgical procedures and p
2015-09-09
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
View Source
FDA Device Recall: IMPLANTE DE ORTHOPEDIA 3/CS Used by medical staff to perform surgical proced
2015-09-09
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
View Source
FDA Device Recall: BREAST PACK-BOD 6/CS Used by medical staff to perform surgical procedures
2015-09-09
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
View Source
FDA Device Recall: LAPAROTOMY PACK 3/CS Used by medical staff to perform surgical procedures
2015-09-09
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
View Source
FDA Device Recall: ORTHOPEDIC PACK BASIC 5/CS Used by medical staff to perform surgical pro
2015-09-09
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
View Source
FDA Device Recall: LAPAROSCOPY CHOLE 4/CS Used by medical staff to perform surgical procedures and
2015-09-09
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
View Source
FDA Device Recall: LAPAROSCOPY PACK 2/CS Used by medical staff to perform surgical procedures
2015-09-09
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
View Source
FDA Device Recall: FOLEY CATHETER KIT II 18 FR 20/CS Used by medical staff to perform surgical p
2015-09-09
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
View Source
FDA Device Recall: PREMIUM LAPAROTOMY PK CUSTOMED 6/CS Used by medical staff to perform surgical
2015-09-09
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
View Source
FDA Device Recall: OBSTETRICAL SURGICAL PACK 4/CS Used by medical staff to perform surgical p
2015-09-09
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
View Source
FDA Device Recall: KNEE ARTHROSCOPY PK 4/CS Used by medical staff to perform surgical procedures
2015-09-09
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
View Source
FDA Device Recall: GOWN SURG. POLY REINF. XL XLONG 40/CS CUSTOMED Used by medical staff to perf
2015-09-09
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
View Source
FDA Device Recall: HIP ORTHO. PACK 3/CS Used by medical staff to perform surgical procedures a
2015-09-09
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
View Source
FDA Device Recall: DRESSING CHANGE CUSTOMED 50/CS Used by medical staff to perform surgical proc
2015-09-09
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
View Source
FDA Device Recall: CESAREAN PACK 5/CS Used by medical staff to perform surgical procedures and pa
2015-09-09
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
View Source
FDA Device Recall: MAYO STAND COVER W/CSR WRAP 30/CS Used by medical staff to perform surgical pr
2015-09-09
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
View Source
FDA Device Recall: C-SECTION SURGICAL PACK 2/CS Used by medical staff to perform surgical p
2015-09-09
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
View Source
FDA Device Recall: LAPAROTOMY BASIC PACK 10/CS Used by medical staff to perform surgical procedu
2015-09-09
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
View Source
FDA Device Recall: EXTREMITY PACK 4/CS Used by medical staff to perform surgical procedures and
2015-09-09
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
View Source
FDA Device Recall: O.B. PK 4/CS Used by medical staff to perform surgical procedures and pati
2015-09-09
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
View Source
FDA Device Recall: ANGIOGRAPHY PACK CUSTOMED 4/CS Used by medical staff to perform surgical pr
2015-09-09
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
View Source
FDA Device Recall: LAPAROSCOPY PK 4/CS Used by medical staff to perform surgical procedures and p
2015-09-09
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
View Source
FDA Device Recall: FANFOLD DRAPE 44"X58 60/CS Used by medical staff to perform surgical proce
2015-09-09
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
View Source
FDA Device Recall: SHOULDER PACK (I) (2) 6/CS CUSTOMED Used by medical staff to perform surgic
2015-09-09
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
View Source
FDA Device Recall: BASIC PACK W/OUT GOWN 11/CS Used by medical staff to perform surgical procedu
2015-09-09
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
View Source
FDA Device Recall: CESAREAN PACK 4/CS Used by medical staff to perform surgical procedures and pa
2015-09-09
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
View Source
FDA Device Recall: MINOR LAPAROTOMY PK 5/CS Used by medical staff to perform surgical procedures a
2015-09-09
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
View Source
FDA Device Recall: URETHRAL CATHETER TRAY CUSTOMED 50/CS Used by medical staff to perform surgical
2015-09-09
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
View Source
FDA Device Recall: ENDOVENOUS CUSTOM PACK 5/CS CUSTOMED Used by medical staff to perform surgical
2015-09-09
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
View Source
FDA Device Recall: UNIVERSAL PACK 3/CS Used by medical staff to perform surgical procedures and
2015-09-09
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
View Source
FDA Device Recall: CYSTO TUR PACK CUSTOMED 10/CS REV. C 10/13 NON STERILE Used by medical staff to
2015-09-09
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
View Source
FDA Device Recall: GOWN IMPERVIOUS EXTRA LONG 24/CS Used by medical staff to perform surgical pro
2015-09-09
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
View Source
FDA Device Recall: NEURO SPINE PACK 3/CS Used by medical staff to perform surgical procedures
2015-09-09
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
View Source
FDA Device Recall: FOLEY CATH KIT 16FR. W/FOLEY S SENSOR 20/CS Used by medical staff to perform
2015-09-09
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
View Source
FDA Device Recall: LAPAROSCOPY-GYN SURGICAL PACK Used by medical staff to perform surgical procedu
2015-09-09
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
View Source
FDA Device Recall: GAUZE SPONGE 4"X4" 16 PLY SOFT 1280/CS Used by medical staff to perform surgic
2015-09-09
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
View Source
FDA Device Recall: ARTHROSCOPY PACK 3/CS Used by medical staff to perform surgical procedures
2015-09-09
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
View Source
FDA Device Recall: IRRIGATION TRAY W/BULB SYRINGE CUSTOMED 50/CS Used by medical staff to perform
2015-09-09
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
View Source
FDA Device Recall: TUMMY TUCK & BREAST PACK-RFMHI 6/CS Used by medical staff to perform surgi
2015-09-09
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
View Source
FDA Device Recall: INCISION AND DRAINAGE TRAY 50/CS Used by medical staff to perform surgical p
2015-09-09
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
View Source
FDA Device Recall: SHOULDER ARTHROSCOPY PACK 3/CS Used by medical staff to perform surgical proce
2015-09-09
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
View Source
FDA Device Recall: GAUZE 2" X 2" PRODUCTION ONLY 1500PK/CS CUSTOMED Used by medical staff to perf
2015-09-09
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
View Source
FDA Device Recall: SHOULDER ARTHROSCOPY PACK 2/CS Used by medical staff to perform surgical pro
2015-09-09
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
View Source
FDA Device Recall: FEMORAL PACK 5/CS Used by medical staff to perform surgical procedures and
2015-09-09
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
View Source
FDA Device Recall: WOUND MANAG.TRAY 24/CS Used by medical staff to perform surgical procedures a
2015-09-09
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
View Source
FDA Device Recall: SHOULDER PACK 6/CS Used by medical staff to perform surgical procedures and p
2015-09-09
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
View Source
FDA Device Recall: OPEN HEART TRAY 1/CS Used by medical staff to perform surgical procedures an
2015-09-09
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
View Source
FDA Device Recall: LAPAROSCOPY PACK 6/CS Used by medical staff to perform surgical procedures
2015-09-09
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
View Source
FDA Device Recall: ARTHROSCOPY PK 5/CS Used by medical staff to perform surgical procedures and
2015-09-09
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
View Source
FDA Device Recall: OPHTHALMIC PACK 6/CS Used by medical staff to perform surgical procedures and
2015-09-09
Class II — Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
View Source
FDA Recall: Customed, Inc — Class I
20141210
Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled | Product: Laparotomy Pack III (4), catalog #900-...
View Source
FDA Recall: Customed, Inc — Class I
20141210
Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled | Product: Cesarean Pack, Catalog number 900-403....
View Source
FDA Recall: Customed, Inc — Class I
20141210
Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled | Product: Laparoscopy Pack, Catalog number 900-3...
View Source
FDA Recall: Customed, Inc — Class I
20141210
Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled | Product: Femoral Pack, catalog #900-2164 Use...
View Source
FDA Recall: Customed, Inc — Class I
20141210
Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled | Product: Cysto Tur Pack, Catalog number 900-430...
View Source
FDA Recall: Customed, Inc — Class I
20141210
Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manu | Product: Peri Gyn Pack, Catalog number 900-1091...
View Source
FDA Recall: Customed, Inc — Class I
20141210
Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled | Product: Lithotomy Pack, catalog #900-2167 U...
View Source
FDA Recall: Customed, Inc — Class I
20141210
Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled | Product: OB Pack, catalog #900-254 Used by m...
View Source
FDA Recall: Customed, Inc — Class I
20141210
Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manu | Product: OB Pack, Catalog number 900-1717. U...
View Source
FDA Recall: Customed, Inc — Class I
20141210
Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled | Product: O.R. Towels, Catalog number 900-629. ...
View Source
FDA Recall: Customed, Inc — Class I
20141210
Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manu | Product: Endovenous Custom Pack, Catalog number...
View Source
FDA Recall: Customed, Inc — Class I
20141210
Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manu | Product: Wound Closure Tray I, Catalog number 9...
View Source
FDA Recall: Customed, Inc — Class I
20141210
Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manu | Product: Angiography Pack, Catalog number 900-1...
View Source
FDA Recall: Customed, Inc — Class I
20141210
Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manu | Product: Skin Staple Removal, Catalog number 90...
View Source
FDA Recall: Customed, Inc — Class I
20141210
Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manu | Product: Peri Gyn Pack, Catalog number 900-1061...
View Source
FDA Recall: Customed, Inc — Class I
20141210
Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled | Product: Minor Laparotomy Pack, Catalog number ...
View Source
FDA Recall: Customed, Inc — Class I
20141210
Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled | Product: Extremity Arm Pack, catalog #900-2438 ...
View Source
FDA Recall: Customed, Inc — Class I
20141210
Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled | Product: Cysto Tur Pack, catalog #900-2899 U...
View Source
FDA Recall: Customed, Inc — Class I
20141210
Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled | Product: Laparotomy Pack 1 (2 & 3), catalog...
View Source
FDA Recall: Customed, Inc — Class I
20141210
Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manu | Product: Angiography Pack, Catalog number 900-2...
View Source
FDA Recall: Customed, Inc — Class I
20141210
Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled | Product: Hair Restoration Pack, Catalog #900-29...
View Source
FDA Recall: Customed, Inc — Class I
20141210
Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled | Product: ACDF Pack, catalog #900-2917 Used b...
View Source
FDA Recall: Customed, Inc — Class I
20141210
Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled | Product: Cesarean Pack, Catalog # 900-660 Us...
View Source
FDA Recall: Customed, Inc — Class I
20141210
Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled | Product: Urology Pack, Catalog # 900-868 Use...
View Source
FDA Recall: Customed, Inc — Class I
20141210
Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manu | Product: Gown Surgical Fabic Reinforced Large, ...
View Source
FDA Recall: Customed, Inc — Class I
20141210
Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manu | Product: Hip Orthopedia Pack, Catalog number 90...
View Source
FDA Recall: Customed, Inc — Class I
20141210
Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manu | Product: Universal Drainage Tray, Catalog numbe...
View Source
FDA Recall: Customed, Inc — Class I
20141210
Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled | Product: Laparotomy Pack, catalog #900-2516 ...
View Source
FDA Recall: Customed, Inc — Class I
20140910
Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This c | Product: Laparotomy Pack, 900-2516, pack contai...
View Source
FDA Recall: Customed, Inc — Class I
20140910
Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This c | Product: LAPAROSCOPY COLORECTAL SURGICAL PACK ...
View Source
FDA Recall: Customed, Inc — Class I
20140910
Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This c | Product: LAPAROSCOPY PACK- - (1) DRAPE LAP AB...
View Source
FDA Recall: Customed, Inc — Class I
20140910
Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This c | Product: ARTHROSCOPY PACK I (1) CUSTOMED C...
View Source
FDA Recall: Customed, Inc — Class I
20140910
Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This c | Product: PEDIATRIC LAP PACK - ( I) SHEET MINO...
View Source
FDA Recall: Customed, Inc — Class I
20140910
Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This c | Product: PREMIUM OPHTHALMIC PACK- CUSTOMED- ...
View Source
FDA Recall: Customed, Inc — Class I
20140910
Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This c | Product: FOLEY CATHETER KIT 1116FR. - CUSTOM ED...
View Source
FDA Recall: Customed, Inc — Class I
20140910
Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This c | Product: ACDFPACK SURGICAL CENTER, CODE 900-29...
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FDA Recall: Customed, Inc — Class I
20140910
Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This c | Product: UMBILICAL VESSEL CATHETER KIT - CUSTOM...
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FDA Recall: Customed, Inc — Class I
20140910
Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This c | Product: Shoulder Pack, Code 900-2616, contains...
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FDA Recall: Customed, Inc — Class I
20140910
Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This c | Product: Liposuction Pack MRT, code 900-2656, c...
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FDA Recall: Customed, Inc — Class I
20140910
Customed has determined that there is the possibility that packaging integrity may be compromised on differ catalog numbers (multiple lots). This coul | Product: ANGIOGRAPHY PACK CONTENTS: (4) CLO...
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FDA Recall: Customed, Inc — Class I
20140910
Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This c | Product: RETINA PACK - (1) TABLE COVER REINFO...
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FDA Recall: Customed, Inc — Class I
20140910
Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This c | Product: CESAREAN PACK - - (7) TOWELS ABSORBE...
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FDA Recall: Customed, Inc — Class I
20140910
Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This c | Product: Customed O.B. Pack convenience pack ...
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FDA Recall: Customed, Inc — Class I
20140910
Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This c | Product: Customed Femoral Pack , convenience pa...
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FDA Recall: Customed, Inc — Class I
20140910
Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This c | Product: Urology Pack, 900-2510, package contai...
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FDA Recall: Customed, Inc — Class I
20140910
Customed has determined that there is the possibility that packaging integrity may be compromised on differ catalog numbers (multiple lots). This coul | Product: ORTHOPEDIC SURGICAL PACK HOSPITAL S...
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FDA Recall: Customed, Inc — Class I
20140910
Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This c | Product: O.B. PACK - (I) TABLE COVER REINFORC...
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FDA Recall: Customed, Inc — Class I
20140910
Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This c | Product: ARTHROSCOPY PACK - - (1) MAYO STAND...
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FDA Recall: Customed, Inc — Class I
20140910
Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This c | Product: LAPAROSCOPY PACK - (1) TUBING INS...
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FDA Recall: Customed, Inc — Class I
20140910
Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This c | Product: VAGINAL PROCEDURE PACK CUSTOM ED CO...
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FDA Recall: Customed, Inc — Class I
20140910
Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This c | Product: Laparoscopy pack, , Code 900-3178, con...
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FDA Recall: Customed, Inc — Class I
20140910
Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This c | Product: LAPAROSCOPY CHOLE PACK - (4) DRAPE U...
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FDA Recall: Customed, Inc — Class I
20140910
Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This c | Product: FOLEY CATHETER KIT 1118FR.- CUSTOM ED ...
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FDA Recall: Customed, Inc — Class I
20140910
Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This c | Product: Cirugia Cardiovascular Case Cart, c od...
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FDA Recall: Customed, Inc — Class I
20140910
Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This c | Product: LAPAROTOMY PACK - (I) UTILITY BOWL 16o...
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FDA Device Recall: Laparotomy Pack III (4), catalog #900-2492 Used by medical staff to perform p
2014-12-10
Class I — Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions incre...
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FDA Device Recall: Cesarean Pack, Catalog number 900-403. Used by medical staff to perform patie
2014-12-10
Class I — Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions incre...
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FDA Device Recall: Laparoscopy Pack, Catalog number 900-3178. Used by medical staff to perform p
2014-12-10
Class I — Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions incre...
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FDA Device Recall: Femoral Pack, catalog #900-2164 Used by medical staff to perform patient care
2014-12-10
Class I — Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions incre...
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FDA Device Recall: Cysto Tur Pack, Catalog number 900-430 Used by medical staff to perform pati
2014-12-10
Class I — Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions incre...
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FDA Device Recall: Peri Gyn Pack, Catalog number 900-1091. Used by medical staff to perform pati
2014-12-10
Class I — Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and...
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FDA Device Recall: Lithotomy Pack, catalog #900-2167 Used by medical staff to perform patient ca
2014-12-10
Class I — Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions incre...
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FDA Device Recall: OB Pack, catalog #900-254 Used by medical staff to perform patient care proce
2014-12-10
Class I — Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions incre...
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FDA Device Recall: OB Pack, Catalog number 900-1717. Used by medical staff to perform patient ca
2014-12-10
Class I — Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and...
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FDA Device Recall: O.R. Towels, Catalog number 900-629. Used by medical staff to perform patient
2014-12-10
Class I — Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions incre...
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FDA Device Recall: Endovenous Custom Pack, Catalog number 900-1937. Used by medical staff to per
2014-12-10
Class I — Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and...
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FDA Device Recall: Wound Closure Tray I, Catalog number 900-063. Used by medical staff to perfor
2014-12-10
Class I — Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and...
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FDA Device Recall: Angiography Pack, Catalog number 900-1488. Used by medical staff to perform p
2014-12-10
Class I — Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and...
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FDA Device Recall: Skin Staple Removal, Catalog number 900-782. Used by medical staff to perform
2014-12-10
Class I — Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and...
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FDA Device Recall: Peri Gyn Pack, Catalog number 900-1061. Used by medical staff to perform pati
2014-12-10
Class I — Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and...
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FDA Device Recall: Minor Laparotomy Pack, Catalog number 900-450. Used by medical staff to perfo
2014-12-10
Class I — Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions incre...
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FDA Device Recall: Extremity Arm Pack, catalog #900-2438 Used by medical staff to perform patien
2014-12-10
Class I — Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions incre...
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FDA Device Recall: Cysto Tur Pack, catalog #900-2899 Used by medical staff to perform patient ca
2014-12-10
Class I — Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions incre...
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FDA Device Recall: Laparotomy Pack 1 (2 & 3), catalog #900-2490 Used by medical staff to per
2014-12-10
Class I — Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions incre...
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FDA Device Recall: Angiography Pack, Catalog number 900-2038. Used by medical staff to perform p
2014-12-10
Class I — Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and...
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FDA Device Recall: Hair Restoration Pack, Catalog #900-2966 Used by medical staff to perform pat
2014-12-10
Class I — Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions incre...
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FDA Device Recall: ACDF Pack, catalog #900-2917 Used by medical staff to perform patient care pr
2014-12-10
Class I — Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions incre...
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FDA Device Recall: Cesarean Pack, Catalog # 900-660 Used by medical staff to perform patient car
2014-12-10
Class I — Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions incre...
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FDA Device Recall: Urology Pack, Catalog # 900-868 Used by medical staff to perform patient care
2014-12-10
Class I — Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions incre...
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FDA Device Recall: Gown Surgical Fabic Reinforced Large, Catalog number 900-2569. Used by medica
2014-12-10
Class I — Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and...
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FDA Device Recall: Hip Orthopedia Pack, Catalog number 900-1835. Used by medical staff to perfor
2014-12-10
Class I — Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and...
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FDA Device Recall: Universal Drainage Tray, Catalog number 900-032. Used by medical staff to per
2014-12-10
Class I — Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and...
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FDA Device Recall: Laparotomy Pack, catalog #900-2516 Used by medical staff to perform patient c
2014-12-10
Class I — Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions incre...
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FDA Device Recall: Surgeon Gown Poly Reinforced Lgc, Catalog number 900-522. Used by medical sta
2014-12-10
Class I — Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and...
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FDA Device Recall: Shoulder Pack, catalog #900-2616 Used by medical staff to perform patient car
2014-12-10
Class I — Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions incre...
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FDA Device Recall: Pery Gyn Pack, Catalog number 900-635. Used by medical staff to perform patie
2014-12-10
Class I — Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions incre...
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FDA Device Recall: Laparotomy Pack, Catalog number 900-176. Used by medical staff to perform pat
2014-12-10
Class I — Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and...
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FDA Device Recall: Foley Catheter Kit, Catalog number 900-1139 Used by medical staff to perform
2014-12-10
Class I — Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and...
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FDA Device Recall: Open Heart Pack, catalog #900-2618 Used by medical staff to perform patient c
2014-12-10
Class I — Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions incre...
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FDA Device Recall: Minor Laceration Tray, Catalog number 900-1765. Used by medical staff to perf
2014-12-10
Class I — Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and...
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FDA Device Recall: O.B. Pack, Catalog number 900-645. Used by medical staff to perform patient c
2014-12-10
Class I — Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions incre...
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FDA Device Recall: Breast Pack Used by medical staff to perform patient care procedures such as
2014-12-10
Class I — Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions incre...
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FDA Device Recall: Wound Closure Tray II, Catalog number 900-064. Used by medical staff to perfo
2014-12-10
Class I — Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and...
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FDA Device Recall: Laparoscopy Chole Pack, Catalog number 900-414. Used by medical staff to perf
2014-12-10
Class I — Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions incre...
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FDA Device Recall: Laminectomy Pack, Catalog number 900-1202. Used by medical staff to perform p
2014-12-10
Class I — Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and...
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FDA Device Recall: Premium Laparotomy Pack, Catalog number 900-1296. Used by medical staff to pe
2014-12-10
Class I — Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and...
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FDA Device Recall: Plastic Surgery Pack, Catalog number 900-1402. Used by medical staff to perfo
2014-12-10
Class I — Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and...
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FDA Device Recall: Laparotomy Pack, Catalog # 900-848 Used by medical staff to perform patient c
2014-12-10
Class I — Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions incre...
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FDA Device Recall: Gown Fabric Reinforced XXL, Catalog number 900-2567. Used by medical staff to
2014-12-10
Class I — Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and...
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FDA Device Recall: Tummy Tuck Pack, Catalog #900-3026 Used by medical staff to perform patient c
2014-12-10
Class I — Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions incre...
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FDA Device Recall: Arthroscopy Pack, Catalog number 900-620. Used by medical staff to perform pa
2014-12-10
Class I — Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions incre...
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FDA Device Recall: Universal Pack, Catalog number 900-1936. Used by medical staff to perform pat
2014-12-10
Class I — Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and...
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FDA Device Recall: Universal Pack, Catalog number 900-1587. Used by medical staff to perform pat
2014-12-10
Class I — Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and...
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FDA Device Recall: Incision & Drainage Tray, Catalog number 900-774. Used by medical staff to pe
2014-12-10
Class I — Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and...
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FDA Device Recall: Orthopedic Pack, catalog #900-2830 Used by medical staff to perform patient c
2014-12-10
Class I — Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions incre...
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FDA Device Recall: Cysto Tur Pack, Catalog number 900-080. Used by medical staff to perform pati
2014-12-10
Class I — Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and...
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FDA Device Recall: Angiography Pack, catalog #900-210 Used by medical staff to perform patient c
2014-12-10
Class I — Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions incre...
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FDA Device Recall: Open Heart Tray, Catalog number 900-1393. Used by medical staff to perform pa
2014-12-10
Class I — Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and...
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FDA Device Recall: Mayo Stand Cover W/CSR Wrap, Catalog number 900-1771. Used by medical staff t
2014-12-10
Class I — Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and...
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FDA Device Recall: Tracheotomy Care Kit, Catalog number 900-110. Used by medical staff to perfor
2014-12-10
Class I — Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and...
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FDA Device Recall: Angiodrape Pack, Catalog number 900-002. Used by medical staff to perform pat
2014-12-10
Class I — Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and...
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FDA Device Recall: Arthroscopy Pack, catalog #900-2473 Used by medical staff to perform patient
2014-12-10
Class I — Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions incre...
View Source
FDA Device Recall: Laparoscopy OB GYN Pack, Catalog number 900-1192. Used by medical staff to pe
2014-12-10
Class I — Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and...
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FDA Device Recall: Gown Surgical Poly Reinforced XL X-Long, Catalog number 900-2565. Used by med
2014-12-10
Class I — Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and...
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FDA Device Recall: Cirugia Cardiovascular Case Cart, Catalog number 900-1415A. Used by medical s
2014-12-10
Class I — Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and...
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FDA Device Recall: General Minor Pack, Catalog # 900-787 Used by medical staff to perform patien
2014-12-10
Class I — Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions incre...
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FDA Device Recall: Reemplazo de Rodilla y Cadera Knee and Hip Replacement tray, Catalog #2726 Us
2014-12-10
Class I — Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions incre...
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FDA Device Recall: Premium Cesarean Pack, Catalog number 900-1294 Used by medical staff to perf
2014-12-10
Class I — Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and...
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FDA Device Recall: Breat Pack-TPSC, Catalog number 900-3431. Used by medical staff to perform pa
2014-12-10
Class I — Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions incre...
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FDA Device Recall: Ophtalmic Pack, Catalog number 900-1780. Used by medical staff to perform pat
2014-12-10
Class I — Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and...
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FDA Device Recall: Gown Surgical Fabric Reinforced XL, Catalog number 900-2568. Used by medical
2014-12-10
Class I — Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and...
View Source
FDA Device Recall: Cesarean Pack, Catalog number 900-410. Used by medical staff to perform patie
2014-12-10
Class I — Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions incre...
View Source
FDA Device Recall: Gown Surg Fully Impervious Large, Catalog number 900-2564. Used by medical st
2014-12-10
Class I — Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and...
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FDA Device Recall: Laparoscopy Pack, Catalog number 900-028. Used by medical staff to perform pa
2014-12-10
Class I — Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and...
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FDA Device Recall: C-Section Pack, Catalog # 900-998 Used by medical staff to perform patient ca
2014-12-10
Class I — Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions incre...
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FDA Device Recall: Dressing Change, Catalog number 900-1538. Used by medical staff to perform pa
2014-12-10
Class I — Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and...
View Source
FDA Device Recall: Shoulder Arthroscopy Pack, catalog #900-2193 Used by medical staff to perform
2014-12-10
Class I — Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions incre...
View Source
FDA Device Recall: Urology Pack, Catalog number 900-1738. Used by medical staff to perform patie
2014-12-10
Class I — Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and...
View Source
FDA Device Recall: Cesarean Pack, Catalog number 900-1719. Used by medical staff to perform pati
2014-12-10
Class I — Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and...
View Source
FDA Device Recall: Pery GYN Surgical Pack, Catalog number 900-548A. Used by medical staff to per
2014-12-10
Class I — Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions incre...
View Source
FDA Device Recall: Foley Catheter Kit, Catalog number 900-1127. Used by medical staff to perform
2014-12-10
Class I — Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and...
View Source
FDA Device Recall: Neuro Pack, catalog #900-2256 Used by medical staff to perform patient care p
2014-12-10
Class I — Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions incre...
View Source
FDA Device Recall: O.B. Pack, Catalog number 900-012. Used by medical staff to perform patient c
2014-12-10
Class I — Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and...
View Source
FDA Device Recall: Arthroscopy Pack, Catalog number 900-1062. Used by medical staff to perform p
2014-12-10
Class I — Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and...
View Source
FDA Device Recall: Surgical Pack, catalog #900-2224 Used by medical staff to perform patient car
2014-12-10
Class I — Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions incre...
View Source
FDA Device Recall: Orthopedic tray, Catalog number 900-1985 Used by medical staff to perform pa
2014-12-10
Class I — Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and...
View Source
FDA Device Recall: Urology Pack, Catalog number 900-1521. Used by medical staff to perform patie
2014-12-10
Class I — Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and...
View Source
FDA Device Recall: Minor Pack, catalog #900-2511 Used by medical staff to perform patient care p
2014-12-10
Class I — Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions incre...
View Source
FDA Device Recall: Vaginal Procedure Pack, catalog #900-2385 Used by medical staff to perform pa
2014-12-10
Class I — Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions incre...
View Source
FDA Device Recall: Knee Arthroscopy Pack, catalog #900-2123 Used by medical staff to perform pat
2014-12-10
Class I — Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions incre...
View Source
FDA Device Recall: Face Lift, Catalog number 900-3083. Used by medical staff to perform patient
2014-12-10
Class I — Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions incre...
View Source
FDA Device Recall: Laparoscopy Premium Pack, Catalog number 900-1803. Used by medical staff to p
2014-12-10
Class I — Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and...
View Source
FDA Device Recall: Minor Laparotomy Pack, Catalog number 900-1735. Used by medical staff to perf
2014-12-10
Class I — Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and...
View Source
FDA Device Recall: Gown Surgical Non Reinforced XL, Catalog number 900-1579. Used by medical sta
2014-12-10
Class I — Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and...
View Source
FDA Device Recall: Strabismus And Plastic Pack, Catalog # 900-946 Used by medical staff to perfo
2014-12-10
Class I — Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions incre...
View Source
FDA Device Recall: Laparoscopy Colorectal Surgical Pack, catalog #900-2259A Used by medical staf
2014-12-10
Class I — Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions incre...
View Source
FDA Device Recall: Laparoscopy and Pack (1)(2), catalog #900-2483 Used by medical staff to perfo
2014-12-10
Class I — Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions incre...
View Source
FDA Device Recall: Surgical packs (includes trays, bags and kits) Used by medical staff to perfo
2014-12-10
Class I — Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes (QSR) and uncontroll...
View Source
FDA Device Recall: D&C Laparoscopy Pack, Catalog number 900-1496. Used by medical staff to perfo
2014-12-10
Class I — Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and...
View Source
FDA Device Recall: Transverse Laparotomy Pack (8), catalog #900-2491 Used by medical staff to pe
2014-12-10
Class I — Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions incre...
View Source
FDA Device Recall: Reyito Urological Pack, Catalog number 900-1460. Used by medical staff to per
2014-12-10
Class I — Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and...
View Source
FDA Device Recall: Urology Pack, catalog #900-2510 Used by medical staff to perform patient care
2014-12-10
Class I — Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions incre...
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FDA Device Recall: Arthroscopy Pack, catalog #900-2609 Used by medical staff to perform patient
2014-12-10
Class I — Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions incre...
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FDA Device Recall: Shoulder Pack, catalog #900-2766 Used by medical staff to perform patient car
2014-12-10
Class I — Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions incre...
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FDA Device Recall: Basic Pack 1 (III), catalog #900-2471 Used by medical staff to perform patien
2014-12-10
Class I — Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions incre...
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FDA Device Recall: Arthroscopy Pack, Catalog # 900-902 Used by medical staff to perform patient
2014-12-10
Class I — Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions incre...
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FDA Device Recall: Arthroscopy Pack, Catalog number 900-1832. Used by medical staff to perform p
2014-12-10
Class I — Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and...
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FDA Device Recall: Utility Drape End Product, Catalog number 900-582. Used by medical staff to p
2014-12-10
Class I — Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and...
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FDA Device Recall: Arthroscopy Pack, Catalog number 900-1042. Used by medical staff to perform
2014-12-10
Class I — Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and...
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FDA Device Recall: Laparoscopy Cholecystectomy Surgical Pack, Catalog number 900-576A. Used by m
2014-12-10
Class I — Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions incre...
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FDA Device Recall: Cirugia Cardiovascular Case Cart, Catalog number 900-1500. Used by medical st
2014-12-10
Class I — Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and...
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FDA Device Recall: Hip & Knee Replacement, catalog #900-2614 Used by medical staff to perfor
2014-12-10
Class I — Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions incre...
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FDA Device Recall: OB Pack, Catalog number 900-1030. Used by medical staff to perform patient ca
2014-12-10
Class I — Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and...
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FDA Device Recall: Arthoscopy Pack, Catalog # 900-982 Used by medical staff to perform patient c
2014-12-10
Class I — Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions incre...
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FDA Device Recall: Laparotomy Pack, catalog #900-2829 Used by medical staff to perform patient c
2014-12-10
Class I — Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions incre...
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FDA Device Recall: Gown Impervious Extra Long X-Large with Towel & Wrap, Catalog number 900-3190.
2014-12-10
Class I — Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions incre...
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FDA Device Recall: Laparoscopy Chole Pack, Catalog number 900-1059. Used by medical staff to per
2014-12-10
Class I — Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and...
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FDA Device Recall: Ophtalmic Pack, Catalog number 900-1933. Used by medical staff to perform pa
2014-12-10
Class I — Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and...
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FDA Device Recall: Higado & Pancrea Pack, Catalog number 900-1966. Used by medical staff to perf
2014-12-10
Class I — Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and...
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FDA Device Recall: , Catalog # 900-913 Used by medical staff to perform patient care procedures
2014-12-10
Class I — Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions incre...
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FDA Device Recall: Wound Management Tray, Catalog number 900-1154. Used by medical staff to perf
2014-12-10
Class I — Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and...
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FDA Device Recall: Basic Pack W/Out Gown, Catalog number 900-345. Used by medical staff to perfo
2014-12-10
Class I — Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions incre...
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FDA Device Recall: Wound Management Tray II, Catalog number 900-1198. Used by medical staff to p
2014-12-10
Class I — Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and...
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FDA Device Recall: Leggings W/7'' Cuff, Catalog number 900-1574. Used by medical staff to perfor
2014-12-10
Class I — Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and...
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FDA Device Recall: General Line Full Body Drape, catalog #900-2262 Used by medical staff to perf
2014-12-10
Class I — Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions incre...
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FDA Device Recall: Pediatric Lap Pack, Catalog number 900-1383 Used by medical staff to perform
2014-12-10
Class I — Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and...
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FDA Device Recall: Laparotomy Pack, 900-2516, pack contains: ( I) TABLE COVER44" X 90" ( I) CAUT
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient ...
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FDA Device Recall: LAPAROSCOPY COLORECTAL SURGICAL PACK code 900-2259A, contains: (1) SOLUTION S
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient ...
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FDA Device Recall: LAPAROSCOPY PACK- - (1) DRAPE LAP ABDOMINAL WITH POUCH (1) CAMARA DRAPE 9" X
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient ...
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FDA Device Recall: ARTHROSCOPY PACK I (1) CUSTOMED CONTENTS: (1) TOWELS ABSORBENT 15" X 20"
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient ...
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FDA Device Recall: PEDIATRIC LAP PACK - ( I) SHEET MINOR LAP 102" X 121" X 78" ( I) MAYO STAND C
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient ...
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FDA Device Recall: PREMIUM OPHTHALMIC PACK- CUSTOMED- (1) GOWN SMS X-LARGE STD RAGLAN (1) CUP M
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient ...
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FDA Device Recall: FOLEY CATHETER KIT 1116FR. - CUSTOM ED- (1) WRAPPER 24" X 24" (1) PVP TRIPL
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient ...
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FDA Device Recall: ACDFPACK SURGICAL CENTER, CODE 900-2917. CONTENTS: (1) SOLUTION SURGICAL D
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient ...
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FDA Device Recall: UMBILICAL VESSEL CATHETER KIT - CUSTOMED- (1) PAPER TAPE MEASURE DISP. 24" (
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient ...
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FDA Device Recall: Shoulder Pack, Code 900-2616, contains: (2) TUBE SUCTION CONNECT Y."X12' UF (
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient ...
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FDA Device Recall: Liposuction Pack MRT, code 900-2656, contains: (1) NEEDLE HYPODERMIC 27 X 1 LI
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient ...
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FDA Device Recall: ANGIOGRAPHY PACK CONTENTS: (4) CLOTH HUCK TOWEL BLUE (1) TABLE COVER REINFO
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on differ catalog numbers (multiple lots). This could result in an injury to the patient due...
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FDA Device Recall: RETINA PACK - (1) TABLE COVER REINFORCED 44" X 78" LIF (50) COTTON TIP APPLIC
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient ...
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FDA Device Recall: CESAREAN PACK - - (7) TOWELS ABSORBENT 15" X 20" (2) SCALPEL WEIGHTED SAFETY
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient ...
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FDA Device Recall: Customed O.B. Pack convenience pack include multiple components: set up cover,
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient ...
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FDA Device Recall: Customed Femoral Pack , convenience pack include multiple components: Syringe 3c
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient ...
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FDA Device Recall: Urology Pack, 900-2510, package contains: (2) TOWELS ABSORBENT 15X 20 UF (1)
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient ...
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FDA Device Recall: ORTHOPEDIC SURGICAL PACK HOSPITAL SAN CRISTOBAL CONTENTS: (I) CAUTERY TIP
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on differ catalog numbers (multiple lots). This could result in an injury to the patient due...
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FDA Device Recall: O.B. PACK - (I) TABLE COVER REINFORCED 50" X 90" LIF (I) DRAPE UNDERBUTTOCK W
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient ...
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FDA Device Recall: ARTHROSCOPY PACK - - (1) MAYO STAND COVER REINFORCED LIF (3) TOWELS ABSORBEN
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient ...
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FDA Device Recall: LAPAROSCOPY PACK - (1) TUBING INSUFFLAT SET W/0 RING ADAPTOR LIF (1) DRAPE
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient ...
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FDA Device Recall: VAGINAL PROCEDURE PACK CUSTOM ED CONTENTS: (1) DRAPE LITHOTOMY 110" X 63"
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient ...
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FDA Device Recall: Laparoscopy pack, , Code 900-3178, contains: (1) BULB SYRINGE 60cc LIF (10) GA
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient ...
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FDA Device Recall: LAPAROSCOPY CHOLE PACK - (4) DRAPE UTILITY WITH TAPE LIF (2) ABSORBENT TOWELS
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient ...
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FDA Device Recall: FOLEY CATHETER KIT 1118FR.- CUSTOM ED CONTENTS: (1) WRAPPER 24" X 24" (1) LA
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient ...
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FDA Device Recall: Cirugia Cardiovascular Case Cart, c ode 900-1415A, contains: (1) CIRUGIA CARDIO
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient ...
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FDA Device Recall: LAPAROTOMY PACK - (I) UTILITY BOWL 16oz ( I) ELECTRODE DUAL DEPRES./GROUNDPAD
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient ...
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FDA Device Recall: Liposuction Pack BOD, code 900-3028, contains: (2) GOWN XL SMS IMPERVIOUS REINF
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient ...
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FDA Device Recall: MINOR LAPAROTOMY PACK - (1) TABLE COVER 50" X 90" REINFORCED LIF (1) GOWN SU
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient ...
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FDA Device Recall: NEURO PACK CONTENTS: (4) TOWEL ABSOSRBENT 15" X 20" LIF ( I ) BAG BI OH
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient ...
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FDA Device Recall: CERVICAL PACK ADVANCED AMBULATORY SURGICAL CENTER CONTENTS: (1) COVER TAB
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient ...
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FDA Device Recall: PREMIUM UROLOGY PACK - CUSTOMED- (1) LITHOTOMY DRAPE W/POUCH ANESTH. (2) AB
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient ...
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FDA Device Recall: Face Pack MRT, product code 900-2654, contains: (2) GOWN SOFT SMS STD X-LARGE S
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient ...
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FDA Device Recall: OPHTALMIC PACK - (1) GOWN LGE SMS NON REINF TIWRAP (1) IODINE POVIDONE 1o
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient ...
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FDA Device Recall: LAPAROSCOPIA COLORECTAL PACK CONTENTS: (1) SOLUTION SURGICAL DURAPREP 26m
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient ...
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FDA Device Recall: BASIC PACK - (1) TABLE COVER REINF. LIF (1) MAYO STAND COVER REINF. LIF (2
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient ...
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FDA Device Recall: TLIF PACK SURGICAL CENTER, CODE 900-2918. CONTENTS: (2) SOLUTION SURGICA
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient ...
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FDA Device Recall: 08 PAD PACK II (2,3) CUSTOMED CONTENTS: (3) TOWEL ABSORBENT 15" X 20" (1) B
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient ...
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FDA Device Recall: ORTHO PACK EXTREMITY CUSTOMED CONTENTS: (1) TABLE COVER REINFORCED 50" X 9
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient ...
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FDA Device Recall: LAP Abdom w/pouch Customed code 900-2619, contains: (1) DRAPE LAP. ABDOM W/POUC
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient ...
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FDA Device Recall: OB PACK - (2) EXAM GLOVES MED. (1 0) GAUZE SPONGES 4" X 4" 12PL Y (2) LEGGIN
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient ...
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FDA Device Recall: Gown Impervious , Code 900-3190, contains: GOWN IMPERVIOUS EXTRA LONG X-LARGE
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient ...
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FDA Device Recall: Liposuction Pack, code 900-2681, contains: (3) GOWN SOFT SMS STD XLGE SET IN SL
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient ...
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FDA Device Recall: Drape Sheet, Product Code 2942, contains (1) DRAPE % ECONOMY 53 X 77L/F (1) WR
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient ...
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FDA Device Recall: OPHTALMIC PACK- (1) TABLE COVER REINF. 44" X 78" UF (1) GOWN SMS XLGE STD UF
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient ...
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FDA Device Recall: BASIC PACK 1 (Ill) CUSTOMED CONTENTS: (1) TABLE COVER REINFORCED 44" X 78" (4
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient ...
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FDA Device Recall: STRABISMUS & PLASTIC PACK - (1) TABLE COVER REINFORCED 44" X 78" UF (2) GOWN ST
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient ...
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FDA Device Recall: SHOULDER PACK- CUSTOMED- (1) TABLE COVER REINFORCED 50" x 90" LIF (2) MAYO S
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient ...
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FDA Device Recall: KNEE ARTHROSCOPY PACK CONTENTS: (1) TOWEL ABSORBENT 15" X 20" L/F (10)
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient ...
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FDA Device Recall: Hair Restoration Pack- , code 900-2966, contains: (1) MAYO STAND COVER 23X54 (
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient ...
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FDA Device Recall: PREMIUM LAPAROTOMY PACK - CUSTOMED- (1) DRAPE T LAPAROT 102" X 78" X 121" (1)
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient ...
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FDA Device Recall: E..N.T. PACK - (5) SPONGE TONSIL 7/8 XRD (1) TABLE COVER REINFORCED 50" X 90"
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient ...
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FDA Device Recall: Tummy Pack MRT, code 900-2657, contains: (2) GOWN SOFT SMS STD XLGE SET IN SLEE
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient ...
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FDA Device Recall: OB PACK - (1) BABY BLANKET PRINTED (1) BABY BEANIES (1) TABLE COVER REINFORCE
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient ...
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FDA Device Recall: MAJOR LAP PACK - (1) TABLE COVER REINF. 50" X 90" 10) GUZE SPONGE 4" X 4" 16PLY
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient ...
View Source
FDA Device Recall: ANGIODRAPE PACK - - (1) GUIDEWIRE 0.035" X 150cm (2) SYRINGE 10ccWITHOUT NEED
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient ...
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FDA Device Recall: UROLOGY PACK - (3) TOWELS ABSORBENT 15" X 20" UF (1) WASH BASIN ROUND 6QT
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient ...
View Source
FDA Device Recall: UNIVERSAL PACK - (1) UTILITY BOWL 16oz. (1) NEEDLE SPINAL ANEST. 22G X 31!2
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient ...
View Source
FDA Device Recall: HIP ORTHOPEDIA PACK - (1) BLADE SURGICAL #15 STAINLES /STEEL (1) GOWN XL SMS
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient ...
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FDA Device Recall: LAPAROSCOPY GYN PACK - - (1) BLADE SURGICAL #11 STAINLESS STEEL (4) DRAPE UT
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient ...
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FDA Device Recall: PERl GYN PACK - (1) TOWEL NON ABS. W/TAPE L/Free (1) DRAPE UNDERBUTTOCK W/POUC
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient ...
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FDA Device Recall: DRESSING CHANGE - CUSTOMED- (2) GLOVE MED. FREETOUCH VYNIL POWDER FREE ( I
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient ...
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FDA Device Recall: CIRUGIA CARDIOVASCULAR - CASE CART - (1) CIRUGIA CARDIOVASCULAR (PREPARACION)
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient ...
View Source
FDA Device Recall: LAPAROSCOPY CHOLE PACK - (6) TOWELS ABSORBENT 15" X 20" LIF (1) MAYO STAND CO
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on differ catalog numbers (multiple lots). This could result in an injury to the patient due...
View Source
FDA Device Recall: LAPAROSCOPY CHOLECYSTECTOMY PACK - (1) SHEET LAPAROS/ABDOMINAL UF (1) MAYO
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient ...
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FDA Device Recall: O.B. PACK - ( I) PVP SCRUB 8" STICK SPONGES ( I) UNDERBUTTOCK DRAPE WITH POUC
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on differ catalog numbers (multiple lots). This could result in an injury to the patient due...
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FDA Device Recall: Shoulder pack (I) (2), code 900-2515 (1) GOWN IMP. XTRA REINF. XL TOWEL WRAP LE
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient ...
View Source
FDA Device Recall: LUMBAR PACK ADVANCED AMBULATORY SURGICAL CENTER CONTENTS: (1) COVER TABL
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient ...
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FDA Device Recall: ARTHROSCOPY PACK - (1) SURGICAL DURAPREP SOLUTION 26ML LIF (1) ESMARK BANDAGE
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient ...
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FDA Device Recall: UNIVERSAL PACK - (1) TRAY ORGANIZER FULL DEEP (1) ANESTHESIA SPINAL NEEDLE 22
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient ...
View Source
FDA Device Recall: PERY GYN PACK - (1) TABLE COVER REINFORCED 44" X 78" UF (2) TOWEL ABSORBENT
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient ...
View Source
FDA Device Recall: LAPAROTOMY BASIC PACK- CUSTOMED- (1) TABLE COVER REINFORCED 44" X 78" LIF (1)
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient ...
View Source
FDA Device Recall: Endovascular Pack, code 900-2715, contains: ( I) DRAPE FEMORAL ANG. 125 X 75 X
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient ...
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FDA Device Recall: Breast Pack BOD, code 900-3029, contains: (2) GOWN X-LARGE SMS IMPERVIOUS REINF
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient ...
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FDA Device Recall: Chole Cystectomy All Endo System , code 900-3025, contains: (1) TABLE COVER 44X
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient ...
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FDA Device Recall: NEURO PACK- (1)TABLE COVER 44" x 90" (1) GOWN SURGEON REINFORCED X-LARGE TIWR
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient ...
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FDA Device Recall: LAPAROSCOPY PACK - - (1) MAYO STAND COVER REINFORCED LIF (2) DRAPE % ECONOMY
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient ...
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FDA Device Recall: Face Lift , Code 900-3083, contains: (I) SHEET ENT SPLIT 110" X 77" LIF (I) CO
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient ...
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FDA Device Recall: Shoulder Arthroscopy Pack, code 900-2719, contains: (1 0) GAUZE SPONGES 4 X 4 1
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient ...
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FDA Device Recall: LAPAROTOMY PACK - CONTENTS: ( 1) GOWN XL SMS IMPERVIOUS REINFORCED LIF ( 1)
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient ...
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FDA Device Recall: ARTHROSCOPY PACK- (1) TABLE COVER REINFORCED 50" X 90" (1) PRE PAD WITH CUF
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient ...
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FDA Device Recall: LAPAROSCOPY CHOLE SYSTEM PACK MIAMI METRO CON TENTS: (12) TOWELS CLOTH
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient ...
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FDA Device Recall: FANFOLD DRAPE - CUSTOMED (1) DRAPE SHEET 42" X 57" SMS (1) WRAPPER 24" X 24"
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient ...
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FDA Device Recall: Customed Angiodrape Pack convenience pack include multiple components: syringe
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient ...
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FDA Device Recall: TRANSVERSE LAPAROTOMY PACK (8) CUSTOMED CONTENT: (1) TOWEL ABSORBENT 1
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient ...
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FDA Device Recall: PREMIUM CESAREAN PACK- CUSTOMED- (1)BABY BLANKET IMP. 30" X 30" POLY ABSORBEN
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient ...
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FDA Device Recall: C-SECTION SURGICAL PACK- (1) COVER TABLE REINFORCED 50" X 90" (2) TOWELS ABSO
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient ...
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FDA Device Recall: LAPAROSCOPY ABO PACK (1) (2) CUSTOMED CONTENTS: (1) GOWN SURG. REINFORCED X
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient ...
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FDA Device Recall: Breast pack TPSC, code 900-3431, contains: (1) GOWN LARGE STANDARD SMS AAMIIII
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient ...
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FDA Device Recall: ARTHROSCOPY PACK - (1) MAYO STAND COVER REINFORCED LIF (1 0) GAUZE SPONGES 4
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient ...
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FDA Device Recall: CURATION KIT - CUSTOMED- (10) GAUZE SPONGE 4" X 4" 16PL Y (4) ABSORBENT TIP A
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient ...
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FDA Device Recall: GENERAL PACK - CONTENTS: (4) ABSORBENT TOWEL 15" x 20" LIF (1) MAYO STAND COV
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on differ catalog numbers (multiple lots). This could result in an injury to the patient due...
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FDA Device Recall: Customed Laparotomy Pack , convenience pack include multiple components: drape l
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient ...
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FDA Device Recall: BASIC COSMETIC SURG. PACK CUSTOMED (USA), CODE 900-2915. CONTENTS: (2) TOWE
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient ...
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FDA Device Recall: PERl GYN PACK (1) TABLE COVER 44" x 90" (2) LEGGINS W/7" CUFF 30" x 42" (1
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient ...
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FDA Device Recall: NEURO SPINE PACK CONTENTS: (1) SUTURE BAG FLORAL LIF (1) NEEDLE & BLADE
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient ...
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FDA Device Recall: NEURO SPINE PACK , CODE 900-2765 CONTENTS: (l ) DRAPE INCISION 23" X 1 7"
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient ...
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FDA Device Recall: General Cosmetic Pack FCSC, Code 900-3113, contains: (1) COVER MAYO STAND REINF
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient ...
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FDA Device Recall: ORTHOPEDIC PACK BASIC CODE 900-2830. CONTENTS: (3) TOWELS ABSORBENT 15" X 2
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient ...
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FDA Device Recall: EAR PACK CONTENTS: ( I ) B LADE SU RG ICA L # 15 CARBON STEEL ( I ) EME
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient ...
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FDA Device Recall: LAPAROSCOPY PACK CONTENTS: ( I ) BULB SYRINGE 60cc LIF ( I 0) GAUZE SPONGE
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient ...
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FDA Device Recall: ORTHOPEDIC IMPLANT PACK CUSTOMED USA, CODE 900-2903 CONTENTS: (1) CAUTERY
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient ...
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FDA Device Recall: LAMINECTOMY PACK - ( I) RING BASIN LIF (2) TABLE COVER REINFORCED 50" X 90" L
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient ...
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FDA Device Recall: Breast Pack- FJG, code 900-3118, contains: (2) GOWN LARGE STANDARD SMS AAMIIII
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient ...
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FDA Device Recall: OPEN HEART TRAY - - PACK A ( 1) CV SPLIT DRAPE W/ CLEAR AN EST SCREEN STD SMS
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient ...
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FDA Device Recall: CESAREAN PACK - (1) BABY BLANKET IMP. POLY ABS. (4) ABSORBENT TOWELS 15" x 2
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on differ catalog numbers (multiple lots). This could result in an injury to the patient due...
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FDA Device Recall: LABOR & DELIVERY PAC - 1) NEEDLE HYPODERMIC 18G X 1% ST. (2) DRAPE UNDERBUT
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient ...
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FDA Device Recall: SHOULDER PACK CODE 900-2766 CONTENTS: (1) STAPLE SKIN 35 WIDE LIF (1) *
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient ...
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FDA Device Recall: TOTAL HYCTERECTOMY (I) CANNULA 5MM XCEL SLEEVES LIF ( I ) TROCAR XCEL BL
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient ...
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FDA Device Recall: PREMIUM O.B. PACK - CUSTOMED- (1) TABLE COVER REINFORCED 50" X 90" LIF (10) GA
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient ...
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FDA Device Recall: Open Heart Pack, code 900-2618, contains: (9) DRAPE 60" X 76" REINFORCED LIF (
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient ...
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FDA Device Recall: HIP PACK CONTENTS: (2) TOWELS ABSORBENT 15" X 20" (2) GOWN XL SMS IMPERV.
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient ...
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FDA Device Recall: Minor Pack 900-2511, pack contains: (1) GOWN XLGE SMS IMPERVIOUS REINFORCED AA
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient ...
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FDA Device Recall: BASIC PACK W/OUT GOWN- (1) TABLE COVER REINFORCED 50" X 90" UF (4) DRAPE UTILI
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient ...
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FDA Device Recall: Customed Laparoscopy convenience pack include multiple components: gowns, table
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient ...
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FDA Device Recall: IMPLANTE DE ORTHOPEDIA - ( I) CAUTERY T IP POLI SHER LIF ( I) BAG SUTURE FLO
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient ...
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FDA Device Recall: EAR PACK CONTENTS: (I) CAUTERY PENC IL ROCKER SW I TI-I CH ( I ) EMESIS
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient ...
View Source
FDA Device Recall: CESAREAN PACK- (1) COVER TABLE REINFORCED 50" X 90" (2) TOWELS ABSORBENT 15"
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient ...
View Source
FDA Device Recall: LAPAROSCOPY PACK I (4) CUSTOMED CONTENTS: (1) TOWEL ABSORBENT 15" X 20" LIF
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient ...
View Source
FDA Device Recall: PERY GYN PACK - (1) TABLE COVER REINFORCED 44" X 78" (1) DRAPE UTILITY (2)
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient ...
View Source
FDA Device Recall: CENTRAL LINE DRAPE PACK 1) MASK PROCEDUAL EAR LOOP 120MM HG V/B L/Free (1)
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient ...
View Source
FDA Device Recall: CESAREAN PACK- - (3) ABSORBENT TOWELS 15" x 20" LIF (1) PLASTIC BOWL WITH LI
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient ...
View Source
FDA Device Recall: CESAREAN PACK - (1) BABY BLANKET IMP. 30" X 30" POLY ABS. (1) NEEDLE & BLADE
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient ...
View Source
FDA Device Recall: Extremity Pack, code 900-2615, contains: (5) LAP SPONGE PREWASH 18" X 18" XRD
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient ...
View Source
FDA Device Recall: LAPAROTOMY PACK- (1) MAYO STAND COVER REINFORCED LIF (10) GAUZE SPONGE 4" X
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient ...
View Source
FDA Device Recall: LAPAROSCOPY GYN PACK - (1) TABLE COVER REINFORCED 44" X 78" (1) LAPAROSCOPY
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient ...
View Source
FDA Device Recall: CESAREAN PACK- (1) BEANNIES BABY LIF (1) TABLE COVER REINFORCED 50" X 90" LIF
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient ...
View Source
FDA Device Recall: LAPAROSCOPY CHOLE PACK - - ( 1) STRIP STERI CLOSURE W' X 4" LIF ( 1) TABLE CO
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient ...
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FDA Device Recall: LAPAROSCOPY OB GYN PACK - (1) DURAPREP SURGICAL SOLUTION 26ML LIF (1) SHEET T
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient ...
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FDA Device Recall: Tummy Tuck Pack, code 900-2684, contains: (3) GOWN SOFT SMS STD XLGE SET IN SLE
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient ...
View Source
FDA Device Recall: CARPALTUNNELLARGE - (1) TABLE COVER 50" X 90" REINFORCED LIF (1) SYRINGE 10c
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient ...
View Source
FDA Device Recall: REEMPLAZO DE RODILLA Y CADERA CONTENTS: (6) TOWELS ABSORBENT 15" X 20"
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient ...
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FDA Device Recall: Breast Implant Pack, Code 900-2660, contains: (1) DRAPE ECONOMY 53 X 77 (3) G
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient ...
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FDA Device Recall: LAPAROSCOPY CHOLE PACK - (1) DRAPE LASER CAMERA WITH ELASTIC 6" X 96" LIF (2)
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient ...
View Source
FDA Device Recall: Universal Pack- - (1) TABLE COVER REINFORCED 50" X 90" LIF (3) TOWEL ABSORBE
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient ...
View Source
FDA Device Recall: Face Pack- BOD, code 900-3027, contains: (2) GOWN XL SMS IMPERVIOUS REINFORCED
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient ...
View Source
FDA Device Recall: LAPAROSCOPY CHOLECYSTECTOMY PACK- (1 0) GAUZE SPONGE 4" X 4" 16 PLY XRD UF (2
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient ...
View Source
FDA Device Recall: LAPAROSCOPY CHOLECYSTECTOMY SURGICAL PACK - - (1) DRAPE LAPAROS/ABDOMINAL
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient ...
View Source
FDA Device Recall: Hip & Knee replacement pack, 900-2614, contains (1) CAUTERY TIP POLISHER UF (1
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient ...
View Source
FDA Device Recall: UROLOGY PACK- (2) SYRINGE 30ML SLIP TIP 1 ML LIF (2) GOWN SURG. REINFORCED LA
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient ...
View Source
FDA Device Recall: MINOR LAPAROTOMY PACK - (1) DRAPE T LAPAROTOMY (1) BAG SUTURE FLORAL LIF (4)
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient ...
View Source
FDA Device Recall: VEIN PACK - (1) GOWN STANDARD LARGE SMS VELCRO/NECK (3) LAP. SPONGES PREWASH
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient ...
View Source
FDA Device Recall: D & C LAPAROSCOPY PACK - (1) TUBING INSUFFLATION OPEN TIP WITHOUT VENT (1) MA
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient ...
View Source
FDA Device Recall: MINOR PACK CONTENTS: (1) TOWELS ABSORBENT 15" X 20" (1) WRAPPER 24" X
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient ...
View Source
FDA Device Recall: MINOR EXTREMITY PACK {2) CUSTOMED CONTENT: (1) GOWN LGE STD SMS VELC/NE T
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient ...
View Source
FDA Device Recall: Customed Cysto Tur Pack, convenience pack include multiple components: legging w
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient ...
View Source
FDA Device Recall: SURGICAL PACK CONTENTS: (1) SUTURE BAG FLORAL (1) WRAPPER 30" X 30" (2)
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient ...
View Source
FDA Device Recall: ARTHROSCOPY PACK- (1) VIDEO CAMERA DRAPE 13cm X 244cm LIF (2) BANDAGE ELASTIC
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient ...
View Source
FDA Device Recall: ORTHOPEDIC PACK Ill (1) CUSTOMED CONTENTS: (1) GOWN XL SMS IMPERVIOUS REIN
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient ...
View Source
FDA Device Recall: CARPAL TUNNEL SURGICAL LARGE PACK (1) COVER TABLE 44" X 90" LIF (1) NEEDLE HY
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient ...
View Source
FDA Device Recall: C-SECTION PACK - (1) TABLE COVER REINFORCED 50" X 90" L/F (3) TOWELS ABSORBEN
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient ...
View Source
FDA Device Recall: Breast Augmentation Pack, Imagenes Cosmetic, code 900-2682: (3) GOWN SOFT SMS S
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient ...
View Source
FDA Device Recall: Customed LABOR & DELIVERY PACK - Includes: (1) TABLE COVER 44" x 90" (2) LEG
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient ...
View Source
FDA Device Recall: ARTHROSCOPY PACK- (2) ABSORBENT TOWELS 15" x 20" LIF (1) TUBE SUCTION CONNECT
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient ...
View Source
FDA Device Recall: PERY GYN PACK- (1) DRAPE UTILITY WITH TAPE (1) DRAPE UNDERBUTIOCK WITH POUCH
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient ...
View Source
FDA Device Recall: UROLOGY PACK- (10) GAUZE SPONGE 4" X 4" 16PLY (1) TUBE SUCTION CONNECT Y." X
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient ...
View Source
FDA Device Recall: Basic Pack FPSC Florham Pack , code 900-2969, contains: (1) COVER TABLE REINFOR
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient ...
View Source
FDA Device Recall: Knee Arthroscopy Pack, code 900-2718, contains: (1 0) GAUZE SPONGES 4 X 4 12PL
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient ...
View Source
FDA Device Recall: Tummy Tuck Pack-BOD , code 900-3026, contains: (2) GOWN X-LARGE SMS IMPERVIOUS
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient ...
View Source
FDA Device Recall: FEMORAL PACK CONTENTS: (2) TOWELS ABSORBENT 15" X 20" LIF (2) DRAPE SHEET
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient ...
View Source
FDA Device Recall: LAP AROSCOPY PACK - (10) GAUZE SPONGE 4" X 4" 16 PLY XRD LIF (1) MAYO STAND C
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient ...
View Source
FDA Device Recall: Obstetrical Surgical pack, code 900-2940, contains: (1) BLANKET RECEIVING 100
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient ...
View Source
FDA Device Recall: CYSTO TUR PACK- - (1) UTILITY BOWL 32oz LIF (1) SPECIMEN CUP WITH CAP 4oz LIF
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient ...
View Source
FDA Device Recall: AV FISTULA PACK- (1) DRAPE T LAPAROT 102" X 78" X121 " STD SMS (3) GOWN SURG.
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient ...
View Source
FDA Device Recall: Open Heart Tray, Pack A, code 900-1196C, contains: (1) TABLE COVER REINFORCED L
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient ...
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FDA Device Recall: PERl GYN PACK- (1) DRAPE UTILITY WITH TAPE UF (2) TOWELS ABSORBENT 15" X 20"
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient ...
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FDA Device Recall: LAPAROSCOPY COLORECTAL SURGICAL PACK CONTENTS: (1) SOLUTION SURGICAL DURA
2014-09-10
Class I — Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient ...
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irs_exempt
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