CFAI
C.F.A.I.
Civic Free Access Intelligence

ARROW INTERNATIONAL INC.

Company NJ
Found in 8 federal databases · 405 total records
co_sos 1 records
CO Business: ARROW INTERNATIONAL, INC. 1997-05-20
FPC | Status: Good Standing | Brooklyn, OH
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EPA (Environmental Protection Agency) 3 records
EPA TRI: ARROW INTERNATIONAL INC.
TRI facility in LUMBERTON, NJ (BURLINGTON County)
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EPA TRI: ARROW INTERNATIONAL INC
TRI facility in READING, PA (BERKS County)
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EPA TRI: ARROW INTERNATIONAL INC
TRI facility in ASHEBORO, NC (RANDOLPH County)
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epa_echo 2 records
EPA ECHO: Arrow Group 2003-09-30
Type: Administrative - Formal
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EPA ECHO: Arrow Group 2003-07-10
Type: Administrative - Formal
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fda 388 records
FDA Recall: ARROW INTERNATIONAL Inc. — Class I 20240612
Teleflex received reports indicating an infrequent condition that, when not identified and corrected promptly, could result in serious health conseque | Product: Arrow FiberOptix Intra-Aortic Balloon ...
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FDA Device Recall: Arrow Arterial Kits and Trays as follows: (1) Arrow Arterial Access Tray with 2024-10-02
Class II — Reports have been received regarding open seals on the packaging.
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FDA Device Recall: Arrow FiberOptix Intra-Aortic Balloon Catheter Kit: a) REF IAB-05830-LWS; b) 2024-06-12
Class I — Teleflex received reports indicating an infrequent condition that, when not identified and corrected promptly, could result in serious health consequences. The issue may manifest as: -failu...
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FDA Device Recall: Arrow UltraFlex Intra-Aortic Balloon Catheter Kit, a) REF IAB-06830-U; b) REF 2024-06-12
Class I — Teleflex received reports indicating an infrequent condition that, when not identified and corrected promptly, could result in serious health consequences. The issue may manifest as: -failu...
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FDA Device Recall: Arrow Ultra 8 IAB Intra-Aortic Balloon Catheter Kit, a) REF IAB-05830-U; b) RE 2024-06-12
Class I — Teleflex received reports indicating an infrequent condition that, when not identified and corrected promptly, could result in serious health consequences. The issue may manifest as: -failu...
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FDA Recall: ARROW INTERNATIONAL Inc. — Class I 20231011
This recall has been initiated due to reports that the product code and product name were incorrectly listed on the lidstock of affected kits. | Product: Arrow ErgoPack Pressure Injectable Arrowg+ard ...
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FDA Recall: ARROW INTERNATIONAL Inc. — Class II 20230927
This recall has been initiated due to reports that the product code and product name were incorrectly listed on the lidstock of affected kits. | Product: Arrow ErgoPack Pressure Injectable One-Lumen P...
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FDA Device Recall: Arrow ErgoPack Pressure Injectable Arrowg+ard Blue Advance Three-Lumen PICC pre- 2023-10-11
Class I — This recall has been initiated due to reports that the product code and product name were incorrectly listed on the lidstock of affected kits.
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FDA Device Recall: Arrow ErgoPack Complete, Pressure Injectable Arrowg+ard Blue Plus¿ Four-Lumen CV 2023-10-11
Class I — This recall has been initiated due to reports that the product code and product name were incorrectly listed on the lidstock of affected kits.
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FDA Device Recall: Arrow ErgoPack Pressure Injectable One-Lumen PICC, REF CDC-05541-HPK1A; catheter 2023-09-27
Class II — This recall has been initiated due to reports that the product code and product name were incorrectly listed on the lidstock of affected kits.
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FDA Device Recall: Arrow ErgoPack, Pressure Injectable Two-Lumen PICC pre-loaded with Arrow VPS Sty 2023-09-27
Class II — This recall has been initiated due to reports that the product code and product name were incorrectly listed on the lidstock of affected kits.
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FDA Device Recall: ARROW Endurance Extended Dwell Peripheral Catheter System 2023-06-28
Class I — Potential for catheter separation or leakage
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FDA Recall: ARROW INTERNATIONAL Inc. — Class I 20221221
There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. | Product: Arrow AutoCAT2 Intra-Aortic Balloon Pump, AEROAUTOCAT2 WAVE REFURBISHED, R...
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FDA Recall: ARROW INTERNATIONAL Inc. — Class I 20221221
There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. | Product: Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF...
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FDA Recall: ARROW INTERNATIONAL Inc. — Class I 20221221
There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. | Product: Arrow AutoCAT2 Intra-Aortic Balloon Pump, AEROAUTOCAT 2 WAVE, REF IAP-0535...
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FDA Device Recall: Arrow AutoCAT2 Intra-Aortic Balloon Pump, AEROAUTOCAT2 WAVE REFURBISHED, REF IA 2022-12-21
Class I — There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
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FDA Device Recall: Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP- 2022-12-21
Class I — There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
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FDA Device Recall: Arrow AutoCAT2 Intra-Aortic Balloon Pump, AEROAUTOCAT 2 WAVE, REF IAP-0535 (IPN 2022-12-21
Class I — There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
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FDA Device Recall: Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/EMEA, REF IAP- 2022-12-21
Class I — There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
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FDA Device Recall: Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/AJLA, REF IAP- 2022-12-21
Class I — There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
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FDA Device Recall: Arrow AutoCAT2 Intra-Aortic Balloon Pump, AEROAUTOCAT2, REF IAP-0435 (IPN000312 2022-12-21
Class I — There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
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FDA Device Recall: Arrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/EMEA, REF IAP-0600 (IPN00 2022-12-21
Class I — There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
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FDA Device Recall: Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP- 2022-12-21
Class I — There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
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FDA Device Recall: Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP- 2022-12-21
Class I — There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
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FDA Device Recall: Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT 2 IAPB, REF IAP-0400 (IPN00030 2022-12-21
Class I — There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
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FDA Device Recall: Arrow AutoCAT 2 Intra-Aortic Balloon Pump, Arrow AutoCAT 2 IABP, REF IAP-0400J 2022-12-21
Class I — There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
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FDA Device Recall: Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP- 2022-12-21
Class I — There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
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FDA Device Recall: Arrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/AJLA, REF IAP-0601(IPN916 2022-12-21
Class I — There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
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FDA Device Recall: Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/AJLA, REF IAP- 2022-12-21
Class I — There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
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FDA Device Recall: Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/EMEA, REF IAP- 2022-12-21
Class I — There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
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FDA Device Recall: Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP- 2022-12-21
Class I — There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
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FDA Device Recall: Arrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/AJLA, REF IAP-0601(IPN917 2022-12-21
Class I — There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
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FDA Device Recall: Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP- 2022-12-21
Class I — There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
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FDA Device Recall: Arrow AutoCAT 2 Intra-Aortic Balloon Pump, Arrow AutoCAT 2 IABP, REF IAP-0400F 2022-12-21
Class I — There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
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FDA Device Recall: Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus REFURBISHED, REF IAP- 2022-12-21
Class I — There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
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FDA Device Recall: ARROW Pressure Injectable Arrowg+ard Blue Advance Two-Lumen Midline Kit, 5.5 Fr, 2022-10-26
Class II — Mislabeling: the corrugate label, lidstock, banner card, and peel sticker accompanying the affected product incorrectly displays a double lumen 5.5 French catheter (and related priming vo...
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FDA Device Recall: Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR Pro 2021-11-24
Class I — 7FR Percutaneous Thrombolytic Device (PTD) Inner lumen (orange) detached from the device basket result in embolization and retrieval with an additional intervention and consequent delay of t...
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FDA Device Recall: Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR Pro 2021-11-24
Class I — 7FR Percutaneous Thrombolytic Device (PTD) Inner lumen (orange) detached from the device basket result in embolization and retrieval with an additional intervention and consequent delay of t...
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FDA Device Recall: Arrow Pacing Catheter Kit-Bipolar Electrode Catheter 5 Fr. 110 cm, Product Code: 2021-07-21
Class II — Marketed without a 510K
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FDA Device Recall: Arrow Temporary Pacing Catheter/Introducer Kit 6Fr. pacing catheter 7Fr. introdu 2021-07-21
Class II — Marketed without a 510K
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FDA Device Recall: Arrow Bipolar Balloon Electrode Catheter 5 Fr. 105 cm, Product Code: AI-07154 - 2021-07-21
Class II — Marketed without a 510K
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FDA Device Recall: Arrow Temporary Pacing Catheter/Introducer Kit 5Fr. pacing catheter 6 Fr. introd 2021-07-21
Class II — Marketed without a 510K
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FDA Device Recall: Arrow OnControl Bone Lesion Biopsy System Tray-11 ga 10 cm Access/13 ga 14 cm Bi 2021-04-14
Class II — Difficulty inserting the biopsy ejector rod into the bone lesion biopsy cannula, preventing the biopsy sample from being collected. Use of a defective device is likely to require immediate ...
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FDA Recall: Arrow International Inc — Class I 20200708
A potential issue with a component within the above-referenced IABPs may impact the ability of the devices to operate. A Component within the IABP is | Product: Arrow AutoCAT2 Intra-Aortic Balloon Pu...
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FDA Recall: Arrow International Inc — Class I 20200708
A potential issue with a component within the above-referenced IABPs may impact the ability of the devices to operate. A Component within the IABP is | Product: Arrow AC3 Optimus Intra-Aortic Balloon...
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FDA Recall: Arrow International Inc — Class I 20200708
A potential issue with a component within the above-referenced IABPs may impact the ability of the devices to operate. A Component within the IABP is | Product: Arrow AutoCAT2 Intra-Aortic Balloon Pu...
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FDA Recall: Arrow International Inc — Class II 20200226
Product lidstock contains the incorrect expiration date for the product | Product: Arrow StimuCath(R) Continuous Nerve Block Kit ASK-05060-CHO1
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FDA Recall: Arrow International Inc — Class II 20200226
Product lidstock contains the incorrect expiration date for the product | Product: Arrow FlexTip Plus(R) Combined Spinal Epidural Catheterization Kit ASK-05560-WH
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FDA Recall: Arrow International Inc — Class II 20200219
There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also | Product: Epidural Catheterization Kit with Flex...
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FDA Recall: Arrow International Inc — Class II 20200219
There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also | Product: FlexTip Plus Epidural Catheterization ...
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FDA Recall: Arrow International Inc — Class II 20200219
There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also | Product: EPIDURAL CATHETERIZATION KIT, Product ...
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FDA Recall: Arrow International Inc — Class II 20200219
There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also | Product: EPIDURAL CATHETERIZATION KIT, Product ...
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FDA Recall: Arrow International Inc — Class II 20200219
There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also | Product: FlexTip Plus Epidural Catheterization ...
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FDA Recall: Arrow International Inc — Class II 20200219
There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also | Product: FlexTip Plus Epidural Catheterization ...
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FDA Device Recall: Cannon II Plus Replacement Hub Set - Product Usage: is indicated for use in the 2020-08-19
Class II — The lidstock states the incorrect expiration date for the product. This issue could result in use of a device that is expired which could potentially lead to an increased risk of infection ...
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FDA Device Recall: Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE, Product Code IAP-0500 2020-07-08
Class I — A potential issue with a component within the above-referenced IABPs may impact the ability of the devices to operate. A Component within the IABP is susceptible to vibration failure result...
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FDA Device Recall: Arrow AC3 Optimus Intra-Aortic Balloon Pump AC3 Optimus IABP NA/AJLA, Product Co 2020-07-08
Class I — A potential issue with a component within the above-referenced IABPs may impact the ability of the devices to operate. A Component within the IABP is susceptible to vibration failure result...
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FDA Device Recall: Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE JAPANESE, Product Code IA 2020-07-08
Class I — A potential issue with a component within the above-referenced IABPs may impact the ability of the devices to operate. A Component within the IABP is susceptible to vibration failure result...
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FDA Device Recall: Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT 2, Product Code IAP-0400 2020-07-08
Class I — A potential issue with a component within the above-referenced IABPs may impact the ability of the devices to operate. A Component within the IABP is susceptible to vibration failure result...
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FDA Device Recall: Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE DUTCH, Product Code IAP-0 2020-07-08
Class I — A potential issue with a component within the above-referenced IABPs may impact the ability of the devices to operate. A Component within the IABP is susceptible to vibration failure result...
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FDA Device Recall: Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE ITALIAN, Product Code IAP 2020-07-08
Class I — A potential issue with a component within the above-referenced IABPs may impact the ability of the devices to operate. A Component within the IABP is susceptible to vibration failure result...
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FDA Device Recall: Arrow StimuCath(R) Continuous Nerve Block Kit ASK-05060-CHO1 2020-02-26
Class II — Product lidstock contains the incorrect expiration date for the product
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FDA Device Recall: Arrow FlexTip Plus(R) Combined Spinal Epidural Catheterization Kit ASK-05560-WH 2020-02-26
Class II — Product lidstock contains the incorrect expiration date for the product
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FDA Device Recall: PICC Set- PR-35052-HPHNM 2020-02-26
Class II — Product lidstock contains the incorrect expiration date for the product
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FDA Device Recall: Arrow FlexTip Plus(R) Epidural Catheterization Kit ASK-05400-CA1 2020-02-26
Class II — Product lidstock contains the incorrect expiration date for the product
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FDA Device Recall: Arrow Central Venous Catheterization Kit ASK-04200-UPM 2020-02-26
Class II — Product lidstock contains the incorrect expiration date for the product
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FDA Device Recall: Arrow PSI Kit for use with 7 - 7.5 Fr. Catheters ASK-09801-UPM 2020-02-26
Class II — Product lidstock contains the incorrect expiration date for the product
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FDA Device Recall: Arrow FlexTip Plus(R) Epidural Catheterization Kit ASK-17019-MSC 2020-02-26
Class II — Product lidstock contains the incorrect expiration date for the product
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FDA Device Recall: Arrow EPIDURAL CATHETERIZATION KIT YC-02220 2020-02-26
Class II — Product lidstock contains the incorrect expiration date for the product
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FDA Device Recall: Arrow EPIDURAL CATHETERIZATION COMPONENT EC-05000 2020-02-26
Class II — Product lidstock contains the incorrect expiration date for the product
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FDA Device Recall: Arrow FlexTip Plus(R) Epidural Catheterization Kit ASK-05500-CAN 2020-02-26
Class II — Product lidstock contains the incorrect expiration date for the product
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FDA Device Recall: Arrow EPIDURAL CATHETERIZATION KIT CK-02220 2020-02-26
Class II — Product lidstock contains the incorrect expiration date for the product
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FDA Device Recall: (1) Arrow¿ STIM CPNB TUOHY NDL: 18G x 14CM (5-1/2") AB-18140-N (2) Arrow¿ STIM 2020-02-26
Class II — Product lidstock contains the incorrect expiration date for the product
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FDA Device Recall: Epidural Catheterization Kit with FlexTip Plus, Open Tip, Single- Port Catheter 2020-02-19
Class II — There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring a blood patch.
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FDA Device Recall: FlexTip Plus Epidural Catheterization Kit, Product Code ASK-05400-CA1 2020-02-19
Class II — There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring a blood patch.
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FDA Device Recall: EPIDURAL CATHETERIZATION KIT, Product Code IT-05400-DC 2020-02-19
Class II — There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring a blood patch.
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FDA Device Recall: EPIDURAL CATHETERIZATION KIT, Product Code JC-05400-LB 2020-02-19
Class II — There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring a blood patch.
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FDA Device Recall: FlexTip Plus Epidural Catheterization Set, Product Code JC-05400-DCS 2020-02-19
Class II — There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring a blood patch.
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FDA Device Recall: FlexTip Plus Epidural Catheterization Set for Pediatric Lumbar Placement, Produc 2020-02-19
Class II — There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring a blood patch.
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FDA Device Recall: FlexTip Plus Epidural Catheterization Set, Product Code AA-05400-E 2020-02-19
Class II — There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring a blood patch.
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FDA Device Recall: TheraCath Epidural Catheterization Kit, Product Code ASK-05001-SLR1 2020-02-19
Class II — There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring a blood patch.
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FDA Device Recall: EPIDURAL CATHETERIZATION KIT, Product Code DE-05400D-BO 2020-02-19
Class II — There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring a blood patch.
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FDA Device Recall: FlexTip Plus Epidural Catheterization Set, Product Code MP-17019-TIP 2020-02-19
Class II — There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring a blood patch.
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FDA Device Recall: EPIDURAL CATHETERIZATION KIT, Product Code UR-05501-EXP 2020-02-19
Class II — There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring a blood patch.
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FDA Device Recall: 10 cc Luer-Slip Loss of Resistance Syringe, Product Code LR-05501 2020-02-19
Class II — There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring a blood patch.
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FDA Device Recall: EPIDURAL CATHETERIZATION KIT, Product Code ALZANO-05400-B 2020-02-19
Class II — There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring a blood patch.
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FDA Device Recall: FlexTip Plus Epidural Catheterization Kit, Product Code ASK-02220-SRH 2020-02-19
Class II — There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring a blood patch.
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FDA Device Recall: FlexTip Plus Epidural Catheterization Kit, Product Code ASK-05500-TM 2020-02-19
Class II — There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring a blood patch.
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FDA Device Recall: EPIDURAL CATHETERIZATION KIT, Product Code BE-05400B-ETTEL 2020-02-19
Class II — There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring a blood patch.
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FDA Device Recall: EPIDURAL CATHETERIZATION KIT, Product Code UR-05501 2020-02-19
Class II — There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring a blood patch.
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FDA Device Recall: FlexTip Plus Epidural Catheterization Kit, Product Code CA-02220 2020-02-19
Class II — There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring a blood patch.
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FDA Device Recall: EPIDURAL CATHETERIZATION KIT, Product Code FR-05501-12 2020-02-19
Class II — There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring a blood patch.
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FDA Device Recall: EPIDURAL CATHETERIZATION KIT, Product Code AT-05501-LEO 2020-02-19
Class II — There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring a blood patch.
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FDA Device Recall: FlexTip Plus Epidural Catheterization Kit, Product Code ASK-17019-MSC 2020-02-19
Class II — There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring a blood patch.
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FDA Device Recall: EPIDURAL CATHETERIZATION KIT, Product Code BE-080180-CHH 2020-02-19
Class II — There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring a blood patch.
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FDA Device Recall: EPIDURAL CATHETERIZATION KIT, Product Code UR-05501-FR1 2020-02-19
Class II — There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring a blood patch.
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FDA Device Recall: EPIDURAL CATHETERIZATION KIT, Product Code BJC-05400-BEN 2020-02-19
Class II — There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring a blood patch.
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FDA Device Recall: EPIDURAL CATHETERIZATION KIT, Product Code MTO-05500-SU 2020-02-19
Class II — There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring a blood patch.
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FDA Device Recall: FlexTip Plus Epidural Catheterization Kit, Product Code AK-05500 2020-02-19
Class II — There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring a blood patch.
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FDA Device Recall: EPIDURAL CATHETERIZATION KIT, Product Code FR-05501-10 2020-02-19
Class II — There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring a blood patch.
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FDA Device Recall: FlexTip Plus Epidural Catheterization Set, Product Code MTO-05500-TK 2020-02-19
Class II — There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring a blood patch.
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FDA Device Recall: FlexTip Plus Combined Spinal Epidural Catheterization Kit, Product Code ASK-0556 2020-02-19
Class II — There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring a blood patch.
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FDA Device Recall: EPIDURAL CATHETERIZATION KIT, Product Code AT-05501-LIN 2020-02-19
Class II — There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring a blood patch.
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FDA Device Recall: Epidural Catheterization Kit with FlexTip Plus Catheter, Product Code TI-05520-E 2020-02-19
Class II — There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring a blood patch.
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FDA Device Recall: FlexTip Plus Epidural Catheterization Kit, Product Code ASK-05501-SH 2020-02-19
Class II — There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring a blood patch.
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FDA Device Recall: FlexTip Plus Combined Spinal Epidural Catheterization Kit, Product Code ASK-0556 2020-02-19
Class II — There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring a blood patch.
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FDA Device Recall: EPIDURAL CATHETERIZATION KIT, Product Code BE-05400-DCSHO 2020-02-19
Class II — There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring a blood patch.
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FDA Device Recall: FlexTip Plus Epidural Catheterization Kit, Product Code MP-17019-TKP 2020-02-19
Class II — There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring a blood patch.
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FDA Device Recall: FlexTip Plus Combined Spinal Epidural Catheterization Set, Product Code AA-05400 2020-02-19
Class II — There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring a blood patch.
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FDA Recall: Arrow International Inc — Class II 20190626
Lidstock states the incorrect expiration date for the product | Product: Arrow JACC with Chlorag+ard Technology Jugular Axillo subclavian Central Catheter
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FDA Recall: Arrow International Inc — Class II 20190626
Lidstock states the incorrect expiration date for the product | Product: Arrowg+ard Blue Advance JACC Product Code: CDC 42063 JX1A
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FDA Recall: Arrow International Inc — Class II 20190626
Lidstock states the incorrect expiration date for the product | Product: Arrow PICC with Chlorag+ard Technology Product Code: CDA 45041 HPK1A
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FDA Recall: Arrow International Inc — Class II 20190626
Lidstock states the incorrect expiration date for the product | Product: Arrow¿ JACC with Chlorag+ard¿ Technology Jugular Axillosubclavian Central Catheter
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FDA Recall: Arrow International Inc — Class II 20190626
Lidstock states the incorrect expiration date for the product | Product: Arrow¿ JACC with Chlorag+ard Technology Product Code:JR 42563 HPHNM
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FDA Recall: Arrow International Inc — Class II 20190626
Lidstock states the incorrect expiration date for the product | Product: Arrow¿ PICC Kit Product Code: ASK 45541 LVH1
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FDA Recall: Arrow International Inc — Class II 20190306
Possible cracks on the body of the fill port connector, which may result in a leak. If the leak is identified while the user is filling the pump, ther | Product: AF w/AS 550 x 1-14ML/HR CPNB, Product ...
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FDA Recall: Arrow International Inc — Class II 20190306
Possible cracks on the body of the fill port connector, which may result in a leak. If the leak is identified while the user is filling the pump, ther | Product: AF w/AS 550 x 1-14 ml/hr, 5ml30 LOCPNB...
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FDA Recall: Arrow International Inc — Class II 20190306
Possible cracks on the body of the fill port connector, which may result in a leak. If the leak is identified while the user is filling the pump, ther | Product: AF 550 x 5ML/H 6" CATH, 4.5" IN, Produ...
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FDA Device Recall: Arrow Berman Angiographic Catheter 60cm Item Number: AI-07130-J 2019-12-25
Class II — Potential leak in the balloon extension line. If a leak was present and went undetected during pre-use testing as outlined in the IFU, this would cause the balloon to deflate slowly followi...
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FDA Device Recall: Arrow Berman Angiographic Catheter 50cc Item Number: AI-07130 2019-12-25
Class II — Potential leak in the balloon extension line. If a leak was present and went undetected during pre-use testing as outlined in the IFU, this would cause the balloon to deflate slowly followi...
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FDA Device Recall: Arrow AGB+ Multi-Lumen CVC Kit-catheter permits venous access to central circula 2019-10-30
Class II — Arrow AGB+ Multi-Lumen CVC Kit - lidstock incorrectly states within CDC-45703-1A a catheter 20cm in length. The banner card correctly states the product is CDC-42703-1A with a catheter 16cm...
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FDA Device Recall: 8.5 Fr. X 10 cm ARROW+gard Blue PSI Kit Cath-Gard for use with 7.5 - 8 Fr.Cathet 2019-10-02
Class II — Products may contain the incorrect banner card within the kit
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FDA Device Recall: Arrow 8.5 Fr. X 16 cm Quad-Lumen Central Venous Catheterization Kit Product Cod 2019-10-02
Class II — Products may contain the incorrect banner card within the kit
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FDA Device Recall: Arrow JACC with Chlorag+ard Technology Jugular Axillo subclavian Central Cathete 2019-06-26
Class II — Lidstock states the incorrect expiration date for the product
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FDA Device Recall: Arrowg+ard Blue Advance JACC Product Code: CDC 42063 JX1A 2019-06-26
Class II — Lidstock states the incorrect expiration date for the product
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FDA Device Recall: Arrow PICC with Chlorag+ard Technology Product Code: CDA 45041 HPK1 2019-06-26
Class II — Lidstock states the incorrect expiration date for the product
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FDA Device Recall: Arrow¿ JACC with Chlorag+ard¿ Technology Jugular Axillosubclavian Central Cathet 2019-06-26
Class II — Lidstock states the incorrect expiration date for the product
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FDA Device Recall: Arrow¿ JACC with Chlorag+ard Technology Product Code:JR 42563 HPHNM 2019-06-26
Class II — Lidstock states the incorrect expiration date for the product
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FDA Device Recall: Arrow¿ PICC Kit Product Code: ASK 45541 LVH1 2019-06-26
Class II — Lidstock states the incorrect expiration date for the product
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FDA Device Recall: Arrowg+ard Blue Advance PICC pre loaded with Arrow¿ VPS" Precision Stylet 2019-06-26
Class II — Lidstock states the incorrect expiration date for the product
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FDA Device Recall: Arrow PICC Kit Product Code: ASK 45541 RWJ4 2019-06-26
Class II — Lidstock states the incorrect expiration date for the product
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FDA Device Recall: Arrow PICC with Chlorag+ard Technology Product Code: CDA 45052 2019-06-26
Class II — Lidstock states the incorrect expiration date for the product
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FDA Device Recall: Arrow¿ PICC with Chlorag+ard¿ Technology Product Code: PR 45552 HPHNL 2019-06-26
Class II — Lidstock states the incorrect expiration date for the product
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FDA Device Recall: Arrow PICC with Chlorag+ard Technology Product Code: CDA 45552 VPS2 2019-06-26
Class II — Lidstock states the incorrect expiration date for the product
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FDA Device Recall: Arrow¿ PICC with Chlorag+ard Technology Product Code:PR 45541 HPHNM 2019-06-26
Class II — Lidstock states the incorrect expiration date for the product
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FDA Device Recall: Arrow¿ JACC with Chlorag+ard¿ Technology Jugular Axillo subclavian Central Cathe 2019-06-26
Class II — Lidstock states the incorrect expiration date for the product
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FDA Device Recall: Arrowg+ard Blue Advance JACC Product Code: CDC 41552 JX1A 2019-06-26
Class II — Lidstock states the incorrect expiration date for the product
View Source
FDA Device Recall: Arrow PICC with Chlorag+ard Technology Product Code: CDA 45541 2019-06-26
Class II — Lidstock states the incorrect expiration date for the product
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FDA Device Recall: Arrowg+ard Blue Advance PICC pre loaded with Arrow¿ VPS" Precision Stylet Pro 2019-06-26
Class II — Lidstock states the incorrect expiration date for the product
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FDA Device Recall: Arrowg+ard Blue Advance JACC Product Code: CDC 42041 JX1A 2019-06-26
Class II — Lidstock states the incorrect expiration date for the product
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FDA Device Recall: Arrow¿ JACC with Chlorag+ard Technology Product Code: JR 42041 HPHNM 2019-06-26
Class II — Lidstock states the incorrect expiration date for the product
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FDA Device Recall: Arrowg+ard Blue Advance PICC Product Code: CDC45541HPK1A 2019-06-26
Class II — Lidstock states the incorrect expiration date for the product
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FDA Device Recall: Arrowg+ard Blue Advance Midline Product Code: PR 41541 BAS 2019-06-26
Class II — Lidstock states the incorrect expiration date for the product
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FDA Device Recall: Arrow PICC Kit Product Code: ASK 45552 RWJ4 2019-06-26
Class II — Lidstock states the incorrect expiration date for the product
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FDA Device Recall: Arrow PICC with Chlorag+ard Technology Product Code: CDA 44052 HPK1A 2019-06-26
Class II — Lidstock states the incorrect expiration date for the product
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FDA Device Recall: Arrowg+ard Blue Advance PICC pre loaded with Arrow¿ VPS" Precision Stylet 2019-06-26
Class II — Lidstock states the incorrect expiration date for the product
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FDA Device Recall: Arrowg+ard Blue Advance PICC pre loaded with Arrow¿ VPS" Precision Stylet Pro 2019-06-26
Class II — Lidstock states the incorrect expiration date for the product
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FDA Device Recall: Arrow PICC powered by Arrow VPS Stylet Product Code: ASK45041JHVA 2019-06-26
Class II — Lidstock states the incorrect expiration date for the product
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FDA Device Recall: Arrowg+ard Blue Advance" PICC pre loaded with Arrow¿ VPS" Precision Stylet Pr 2019-06-26
Class II — Lidstock states the incorrect expiration date for the product
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FDA Device Recall: Arrow PICC powered by Arrow VPS Precision Stylet Product Code:CDC-44052-VPS2 2019-05-22
Class II — Kits labeled as containing a 40 cm PICC may contain a 50 cm PICC, and kits labeled as containing a 50 cm PICC may contain a 40 cm PICC
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FDA Device Recall: Arrow¿ Two-Lumen Central Venous Catheterization Set with Blue FlexTip¿ Catheter 2019-04-17
Class II — The product lidstock contains a labelling error. The lidstock states the incorrect priming volume. The priming volumes printed on the extension lines are correct
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FDA Device Recall: AF w/AS 550 x 1-14ML/HR CPNB, Product code MVBXL- CPNB, Arrow AutoFuser Disposab 2019-03-06
Class II — Possible cracks on the body of the fill port connector, which may result in a leak. If the leak is identified while the user is filling the pump, there may be a delay while an alternative ...
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FDA Device Recall: AF w/AS 550 x 1-14 ml/hr, 5ml30 LOCPNB, Product code MVBX30XLCPNB, Arrow AutoFus 2019-03-06
Class II — Possible cracks on the body of the fill port connector, which may result in a leak. If the leak is identified while the user is filling the pump, there may be a delay while an alternative ...
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FDA Device Recall: AF 550 x 5ML/H 6" CATH, 4.5" IN, Product code MC0050XLSK5 CP, Arrow AutoFuser Di 2019-03-06
Class II — Possible cracks on the body of the fill port connector, which may result in a leak. If the leak is identified while the user is filling the pump, there may be a delay while an alternative ...
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FDA Device Recall: AF 550 x 5ML/H 6" DUAL CATHS, 4.5", Product code MC0050XLYK5 CP, Arrow AutoFuser 2019-03-06
Class II — Possible cracks on the body of the fill port connector, which may result in a leak. If the leak is identified while the user is filling the pump, there may be a delay while an alternative ...
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FDA Device Recall: AF w/AS 550 x 1-14ML/HR 2ML-30LO CPNB, Product code MVBT30XL CPNB, Arrow AutoFus 2019-03-06
Class II — Possible cracks on the body of the fill port connector, which may result in a leak. If the leak is identified while the user is filling the pump, there may be a delay while an alternative ...
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FDA Device Recall: AF w/AS 550 x 1-14ML/HR 2ML-15LO CPNB, Product code MVBT15XL-CPNB, Arrow AutoFus 2019-03-06
Class II — Possible cracks on the body of the fill port connector, which may result in a leak. If the leak is identified while the user is filling the pump, there may be a delay while an alternative ...
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FDA Device Recall: AF w/AS 550 x 1-14ML/HR 5ML-60LO CPNB, Product code MVBX60XL CPNB, Arrow AutoFus 2019-03-06
Class II — Possible cracks on the body of the fill port connector, which may result in a leak. If the leak is identified while the user is filling the pump, there may be a delay while an alternative ...
View Source
FDA Device Recall: AF550x5ML/H 2ML 60LO 6" DUAL CATHS, 4.5", Product MT5060XLYK5 CP, Arrow AutoFuse 2019-03-06
Class II — Possible cracks on the body of the fill port connector, which may result in a leak. If the leak is identified while the user is filling the pump, there may be a delay while an alternative ...
View Source
FDA Device Recall: AF 550 x 5ML/HR 2ML 60LO CPNB, Product code MT5060XL CPNB, Arrow AutoFuser Dispo 2019-03-06
Class II — Possible cracks on the body of the fill port connector, which may result in a leak. If the leak is identified while the user is filling the pump, there may be a delay while an alternative ...
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FDA Device Recall: AF w/AS 550 x 0.5-7 ml,w/Y site,DL CPNB, Product code MVAXL2Y CPNB, Arrow AutoFu 2019-03-06
Class II — Possible cracks on the body of the fill port connector, which may result in a leak. If the leak is identified while the user is filling the pump, there may be a delay while an alternative ...
View Source
FDA Device Recall: AF 550x8ML/H 2ML 15LO 8.7" DUAL CATHS, 4, Product code MT8015XLYK10 CP, Arrow Au 2019-03-06
Class II — Possible cracks on the body of the fill port connector, which may result in a leak. If the leak is identified while the user is filling the pump, there may be a delay while an alternative ...
View Source
FDA Device Recall: 0F 550 x 8ML/HR 2ML 60LO CPNB, Product code MT8060XL CPNB, Arrow AutoFuser Dispo 2019-03-06
Class II — Possible cracks on the body of the fill port connector, which may result in a leak. If the leak is identified while the user is filling the pump, there may be a delay while an alternative ...
View Source
FDA Device Recall: AF 550 x 8ML/HR 2ML 15LO CPNBMT8015XL CP, Product code MT8015XL CPNB, Arrow Auto 2019-03-06
Class II — Possible cracks on the body of the fill port connector, which may result in a leak. If the leak is identified while the user is filling the pump, there may be a delay while an alternative ...
View Source
FDA Recall: Arrow International Inc — Class II 20181121
The products labeling contains inconsistencies. In certain instances, the lidstock, banner card and shipper label state that the Spring Wire Guide (S | Product: Arrow AGB+ Multi-Lumen CVC Kit, 7 Fr.,...
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FDA Recall: Arrow International Inc — Class II 20180606
Product sterility may be compromised due to unsealed packaging. | Product: 4Fr. Catheter Clamp with Fastener; Product Code: CC-00004
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FDA Recall: Arrow International Inc — Class II 20180606
Product sterility may be compromised due to unsealed packaging. | Product: 8Fr. Catheter Clamp with Fastener; Product Code: CC-00008
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FDA Recall: Arrow International Inc — Class II 20180606
Product sterility may be compromised due to unsealed packaging. | Product: Maximal Barrier Drape; Product Code: ASK-04000-HMC
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FDA Recall: Arrow International Inc — Class II 20180606
Product sterility may be compromised due to unsealed packaging. | Product: Pressure Injectable ARROWg+ard Blue PLUS(R) Multi-Lumen Central Venous Catheterization Kit; Product
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FDA Recall: Arrow International Inc — Class II 20180606
Product sterility may be compromised due to unsealed packaging. | Product: Arrow-Flex(R) Percutaneous Sheath Introducer Kit with ARROWg+ard Blue(R) Sheath and Integral Hemosta
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FDA Recall: Arrow International Inc — Class II 20180606
Product sterility may be compromised due to unsealed packaging. | Product: ARROWg+ard Blue PLUS¿ Pressure Injectable Quad-Lumen CVC Kit; Product Codes: CDC-42854-P1A and CDC-4
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FDA Recall: Arrow International Inc — Class II 20180606
Product sterility may be compromised due to unsealed packaging. | Product: Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port and Sharps Safety Featur
View Source
FDA Recall: Arrow International Inc — Class II 20180606
Product sterility may be compromised due to unsealed packaging. | Product: Peel Away Sheath over Dilator; Product Codes: PL-05041 and PL-05052
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FDA Recall: Arrow International Inc — Class II 20180606
Product sterility may be compromised due to unsealed packaging. | Product: Maximal Barrier Drape; Product Codes: ASK-00001-1A
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FDA Recall: Arrow International Inc — Class II 20180606
Product sterility may be compromised due to unsealed packaging. | Product: Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard
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FDA Recall: Arrow International Inc — Class II 20180418
Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed. | Product: (1) Central Venous Catheterization Kit, Part Number (PN): ASK-043...
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FDA Recall: Arrow International Inc — Class II 20180418
Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed. | Product: AGB+ Multi Lumen CVC Kit (1) Part Number (PN): CDC-42703-B1A, (2)...
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FDA Recall: Arrow International Inc — Class II 20180411
The povidone iodine prep pads included in certain kits and trays do not meet the requirements for a 36-month shelf life and should be labeled with a 2 | Product: Radial Artery Catheterization Kit; Mod...
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FDA Recall: Arrow International Inc — Class II 20180328
Products do not contain the Central Venous Catheter Placement Procedures Note or the Central Line Insertion Checklist, which is a tool intended to gui | Product: ARROWg+ard Blue PLUS Pressure Injectab...
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FDA Recall: Arrow International Inc — Class II 20180321
Some of the products listed in the recall may be missing a sticker that contains the lot number, expiration date, and Unique Device Identification (UD | Product: ARROWg+ard BLUE PLUS Pressure Injecta...
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FDA Recall: Arrow International Inc — Class II 20180228
These finished good kits may contain the incorrect Springwire Guide (SWG). | Product: Pressure Injectable Multi Lumen Central Venous Catheterization Kit with Blue FlexTip Catheter and S
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FDA Recall: Arrow International Inc — Class II 20180228
These finished good kits may contain the incorrect Springwire Guide (SWG). | Product: ARROWg+ard Blue Plus Multi Lumen CVC (Central venous catheter); Product Code: AK-45703-ACDC; Exp. Da
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FDA Recall: Arrow International Inc — Class II 20180228
These finished good kits may contain the incorrect Springwire Guide (SWG). | Product: Arrow Multi Lumen CVC Kit (Central venous catheter); Product Code: CDC-15703-1A; Exp. Dates Feb 2018
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FDA Device Recall: Arrow AGB+ Multi-Lumen CVC Kit, 7 Fr., 3 Lumen, 20cm catheter length, .025 inch 2018-11-21
Class II — The products labeling contains inconsistencies. In certain instances, the lidstock, banner card and shipper label state that the Spring Wire Guide (SWG) within is .032 rather than the cor...
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FDA Device Recall: Arrow AGB + Multi-Lumen CVC Kit, Cat. No. CDC-42703-B1A. Product Usage - The Arr 2018-11-07
Class II — The product was shipped after its expiry date due to a system error. The product lidstock identifies the correct expiration date however the accompanying purchase order shipping document...
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FDA Device Recall: 4.5 Fr x 40 cm single-lumen PICC Kit, Product Code CDC-44041-VPS2, 5.5 Fr double 2018-09-26
Class II — The products may contain the incorrect catheter. Kits that should contain a 4.5 Fr single-lumen catheter may contain a 5.5 Fr double-lumen catheter. Kits that should contain a 5.5 Fr double...
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FDA Device Recall: Pediatric Two-Lumen Central Venous Catheterization Kit with Blue FlexTip ARROW 2018-08-29
Class II — One lot of product is from product code AK-22502 so it contains a 2-lumen, 5 Fr x 5 cm catheter. However, this product is incorrectly labeled as AK-25502, so the lidstock says it contains...
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FDA Device Recall: HANDS-OFF Multi-Lumen Central Venous Catheter with Blue FlexTip for use only wit 2018-08-22
Class II — The packaging may not be sealed. If the packaging is compromised in this manner, the sterility of the product cannot be guaranteed.
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FDA Device Recall: HANDS-OFF Multi-Lumen Central Venous Catheter with Blue FlexTip for use only wit 2018-08-22
Class II — The packaging may not be sealed. If the packaging is compromised in this manner, the sterility of the product cannot be guaranteed.
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FDA Device Recall: Peripherally Inserted Midline Catheter Kit with Placement Wire, REF MK-02031-TW 2018-07-18
Class II — Product pouch label may not easily identify the lot number, expiration date and associated symbols..
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FDA Device Recall: VPS TipTracker Stylet Accessory, REF RHY-177-TTSAP Product Usage: To provide 2018-07-18
Class II — Product pouch label may not easily identify the lot number, expiration date and associated symbols..
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FDA Device Recall: VPS Rhythm ECG Accessory Pack, REF RHY-100-ECGO Product Usage: To provide re 2018-07-18
Class II — Product pouch label may not easily identify the lot number, expiration date and associated symbols..
View Source
FDA Device Recall: Multi-Lumen Central Venous Catheterization Set with Blue FlexTip Catheter, CS-15 2018-07-11
Class II — The recalling firm has received complaints related to increased resistance encountered when introducing the CVC over the spring wire guide. This may lead to procedural delay, and there may ...
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FDA Device Recall: 4Fr. Catheter Clamp with Fastener; Product Code: CC-00004 2018-06-06
Class II — Product sterility may be compromised due to unsealed packaging.
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FDA Device Recall: 8Fr. Catheter Clamp with Fastener; Product Code: CC-00008 2018-06-06
Class II — Product sterility may be compromised due to unsealed packaging.
View Source
FDA Device Recall: Maximal Barrier Drape; Product Code: ASK-04000-HMC 2018-06-06
Class II — Product sterility may be compromised due to unsealed packaging.
View Source
FDA Device Recall: Pressure Injectable ARROWg+ard Blue PLUS(R) Multi-Lumen Central Venous Catheteri 2018-06-06
Class II — Product sterility may be compromised due to unsealed packaging.
View Source
FDA Device Recall: Arrow-Flex(R) Percutaneous Sheath Introducer Kit with ARROWg+ard Blue(R) Sheath 2018-06-06
Class II — Product sterility may be compromised due to unsealed packaging.
View Source
FDA Device Recall: ARROWg+ard Blue PLUS¿ Pressure Injectable Quad-Lumen CVC Kit; Product Codes: CDC 2018-06-06
Class II — Product sterility may be compromised due to unsealed packaging.
View Source
FDA Device Recall: Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port and 2018-06-06
Class II — Product sterility may be compromised due to unsealed packaging.
View Source
FDA Device Recall: Peel Away Sheath over Dilator; Product Codes: PL-05041 and PL-05052 2018-06-06
Class II — Product sterility may be compromised due to unsealed packaging.
View Source
FDA Device Recall: Maximal Barrier Drape; Product Codes: ASK-00001-1A 2018-06-06
Class II — Product sterility may be compromised due to unsealed packaging.
View Source
FDA Device Recall: Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue Fle 2018-06-06
Class II — Product sterility may be compromised due to unsealed packaging.
View Source
FDA Device Recall: ARROWg+ard Blue PLUS¿ Pressure Injectable Multi-Lumen CVC Kit; Product Codes: CD 2018-06-06
Class II — Product sterility may be compromised due to unsealed packaging.
View Source
FDA Device Recall: Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard 2018-06-06
Class II — Product sterility may be compromised due to unsealed packaging.
View Source
FDA Device Recall: Epidural Needle; Product Codes: AN-05501 and AN-05505 2018-06-06
Class II — Product sterility may be compromised due to unsealed packaging.
View Source
FDA Device Recall: VPS Rhythm ECG Accessory Pack with Johans Adapter; Product codes: RHY-100-ECGJ 2018-06-06
Class II — Product sterility may be compromised due to unsealed packaging.
View Source
FDA Device Recall: Radial Arterial Access Kit; Product Code: ASK-04001-BID2 2018-06-06
Class II — Product sterility may be compromised due to unsealed packaging.
View Source
FDA Device Recall: Pressure Injectable ARROWg+ard Blue PLUS(R) Two-Lumen Central Venous Catheteriza 2018-06-06
Class II — Product sterility may be compromised due to unsealed packaging.
View Source
FDA Device Recall: Arterial Catheterization Kit; Product Code:NA-04550-1A 2018-06-06
Class II — Product sterility may be compromised due to unsealed packaging.
View Source
FDA Device Recall: Extension Line Slide Clamps; Product codes: SA-09847 2018-06-06
Class II — Product sterility may be compromised due to unsealed packaging.
View Source
FDA Device Recall: Two-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Bl 2018-06-06
Class II — Product sterility may be compromised due to unsealed packaging.
View Source
FDA Device Recall: Radial Artery Catheterization Kit with Sharps Safety Features; Product Codes: AS 2018-06-06
Class II — Product sterility may be compromised due to unsealed packaging.
View Source
FDA Device Recall: Radial Artery Catheterization Kit; Product Codes: ASK-04020-AH, ASK-04020-MIHS, 2018-06-06
Class II — Product sterility may be compromised due to unsealed packaging.
View Source
FDA Device Recall: ARROWgard Blue PLUS Triple-Lumen CVC Kit with Blue FlexTip Catheter; Product Cod 2018-06-06
Class II — Product sterility may be compromised due to unsealed packaging.
View Source
FDA Device Recall: Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard 2018-06-06
Class II — Product sterility may be compromised due to unsealed packaging.
View Source
FDA Device Recall: Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port for 2018-06-06
Class II — Product sterility may be compromised due to unsealed packaging.
View Source
FDA Device Recall: PICC Catheter Trimmer ; Product Code:PC-00001-T 2018-06-06
Class II — Product sterility may be compromised due to unsealed packaging.
View Source
FDA Device Recall: ARROW PICC Set; Product codes: PR-34052-HPHNM, PR-34063-HPHNM, PR-35041-HPHNM, P 2018-06-06
Class II — Product sterility may be compromised due to unsealed packaging.
View Source
FDA Device Recall: VPS Rhythm ECG Accessory Pack ; Product codes: RHY-100-ECGO 2018-06-06
Class II — Product sterility may be compromised due to unsealed packaging.
View Source
FDA Device Recall: TheraCath(R) Epidural Catheter; Product Code: EC-05000 2018-06-06
Class II — Product sterility may be compromised due to unsealed packaging.
View Source
FDA Device Recall: 7Fr. Catheter Clamp with Fastener; Product Code: CC-00007 2018-06-06
Class II — Product sterility may be compromised due to unsealed packaging.
View Source
FDA Device Recall: Maximal Barrier Drape; Product Codes: ASK-00002-1A 2018-06-06
Class II — Product sterility may be compromised due to unsealed packaging.
View Source
FDA Device Recall: Single-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter an 2018-06-06
Class II — Product sterility may be compromised due to unsealed packaging.
View Source
FDA Device Recall: 5Fr. Catheter Clamp with Fastener; Product Code: CC-00005 2018-06-06
Class II — Product sterility may be compromised due to unsealed packaging.
View Source
FDA Device Recall: ARROW JACC with Chlorag+ard Technology; Product Code: JR-42063-HPHNM and JR-4256 2018-06-06
Class II — Product sterility may be compromised due to unsealed packaging.
View Source
FDA Device Recall: ARROWg+ard Blue(R) MAC(TM) Two-Lumen Central Venous Access Kit for use with 7-7. 2018-06-06
Class II — Product sterility may be compromised due to unsealed packaging.
View Source
FDA Device Recall: Percutaneous Sheath Introducer Kit with ARROWgard Blue¿ Sheath and Integral Hem 2018-06-06
Class II — Product sterility may be compromised due to unsealed packaging.
View Source
FDA Device Recall: MAC(TM) Two-Lumen Central Venous Access Kit with ARROWg+ard Blue(R) Access Devic 2018-06-06
Class II — Product sterility may be compromised due to unsealed packaging.
View Source
FDA Device Recall: Percutaneous Sheath Introducer Kit with ARROWg+ard Blue(R) Sheath, Integral Hemo 2018-06-06
Class II — Product sterility may be compromised due to unsealed packaging.
View Source
FDA Device Recall: Sheath Adapter with Cath-Gard¿ Catheter Contamination Shield for use with 4 - 7 2018-06-06
Class II — Product sterility may be compromised due to unsealed packaging.
View Source
FDA Device Recall: Arterial Catheterization Kit; Product Codes: ASK-04020-DH 2018-06-06
Class II — Product sterility may be compromised due to unsealed packaging.
View Source
FDA Device Recall: ARROWg+ard Blue PLUS¿ Pressure Injectable Two-Lumen CVC Kit; Product Code: CDC-4 2018-06-06
Class II — Product sterility may be compromised due to unsealed packaging.
View Source
FDA Device Recall: Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard 2018-06-06
Class II — Product sterility may be compromised due to unsealed packaging.
View Source
FDA Device Recall: Two-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter and S 2018-06-06
Class II — Product sterility may be compromised due to unsealed packaging.
View Source
FDA Device Recall: Echogenic Introducer Needle; Product Code: AN-04318 2018-06-06
Class II — Product sterility may be compromised due to unsealed packaging.
View Source
FDA Device Recall: ARROWg+ard Blue¿ PSI Kit with Integral Hemostasis Valve/ Side Port for use with 2018-06-06
Class II — Product sterility may be compromised due to unsealed packaging.
View Source
FDA Device Recall: Clear Fenestrated Drape with Adhesive; Product Code: CD-00001 2018-06-06
Class II — Product sterility may be compromised due to unsealed packaging.
View Source
FDA Device Recall: Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard 2018-06-06
Class II — Product sterility may be compromised due to unsealed packaging.
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FDA Device Recall: ARROW PICC Set; Product codes: PR-35563-HPHNL and PR-35563-HPHNM 2018-06-06
Class II — Product sterility may be compromised due to unsealed packaging.
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FDA Device Recall: Arrow PICC with Chlorag+ard Technology; Product codes: PR-44041-BAS, PR-44052-B 2018-06-06
Class II — Product sterility may be compromised due to unsealed packaging.
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FDA Device Recall: Catheter Hemostasis Valve For use with .038" (.096 cm) dia. and smaller guide wi 2018-06-06
Class II — Product sterility may be compromised due to unsealed packaging.
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FDA Device Recall: ARROWgard Blue PLUS¿ Multi-Lumen CVC Kit with Blue FlexTip¿ Catheter; Product Co 2018-06-06
Class II — Product sterility may be compromised due to unsealed packaging.
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FDA Device Recall: 9 Fr. Radiopaque Polyurethane Sheath/Dilator with Integral Hemostasis Valve/Si 2018-06-06
Class II — Product sterility may be compromised due to unsealed packaging.
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FDA Device Recall: 0.2 Micron Flat Epidural Filter; Product Code: EF-05500 2018-06-06
Class II — Product sterility may be compromised due to unsealed packaging.
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FDA Device Recall: (1) Central Venous Catheterization Kit, Part Number (PN): ASK-04300-PHP; (2) Sin 2018-04-18
Class II — Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.
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FDA Device Recall: AGB+ Multi Lumen CVC Kit (1) Part Number (PN): CDC-42703-B1A, (2) PN: CDC-42802- 2018-04-18
Class II — Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.
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FDA Device Recall: (1) Access Tray, Part Number (PN): ASK-04001-MS; Arrow Multi-Lumen CVC Kit (2) P 2018-04-18
Class II — Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.
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FDA Device Recall: ARROWg+ard Blue¿ Two-Lumen Hemodialysis Catheterization Kit for High Volume Infu 2018-04-18
Class II — Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.
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FDA Device Recall: (1) ARROWg+ard Blue(R) MAC(TM) Two-Lumen Central Venous Access Kit for use with 2018-04-18
Class II — Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.
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FDA Device Recall: Multi-Lumen Hemodialysis Catheterization Kit for High Volume Infusions, Part Num 2018-04-18
Class II — Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.
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FDA Device Recall: ARROWg+ard Blue¿ CVC Kit (1) Part Number (PN): CDC-24301-1A, (2) PN: CDC-24306-1 2018-04-18
Class II — Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.
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FDA Device Recall: Radial Artery Catheterization Kit; Model: AK-04220 2018-04-11
Class II — The povidone iodine prep pads included in certain kits and trays do not meet the requirements for a 36-month shelf life and should be labeled with a 24-month shelf life.
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FDA Device Recall: Radial Artery Catheterization Kit; Model: AK-04020 2018-04-11
Class II — The povidone iodine prep pads included in certain kits and trays do not meet the requirements for a 36-month shelf life and should be labeled with a 24-month shelf life.
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FDA Device Recall: Pneumothorax Kit 2018-04-11
Class II — Product packaging may not be completely sealed.
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FDA Device Recall: Large Volume Abdominal Paracentesis Kit 2018-04-11
Class II — Product packaging may not be completely sealed.
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FDA Device Recall: Radial Artery Catheterization Kit; Model: AK-04122 2018-04-11
Class II — The povidone iodine prep pads included in certain kits and trays do not meet the requirements for a 36-month shelf life and should be labeled with a 24-month shelf life.
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FDA Device Recall: ARROWg+ard Blue PLUS Pressure Injectable Multi-Lumen CVC Kit. Intended to per 2018-03-28
Class II — Products do not contain the Central Venous Catheter Placement Procedures Note or the Central Line Insertion Checklist, which is a tool intended to guide clinicians in the use of best practi...
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FDA Device Recall: Pressure Injectable Multi- Lumen Central Venous Catheterization Kit with Blue Fl 2018-03-28
Class II — Products do not contain the Central Venous Catheter Placement Procedures Note or the Central Line Insertion Checklist, which is a tool intended to guide clinicians in the use of best practi...
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FDA Device Recall: Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port, Sha 2018-03-28
Class II — Products do not contain the Central Venous Catheter Placement Procedures Note or the Central Line Insertion Checklist, which is a tool intended to guide clinicians in the use of best practi...
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FDA Device Recall: ARROWg+ard BLUE PLUS Pressure Injectable Two- Lumen CVC Kit Product Usage: 2018-03-21
Class II — Some of the products listed in the recall may be missing a sticker that contains the lot number, expiration date, and Unique Device Identification (UDI) information.
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FDA Device Recall: ARROWg+ard Blue¿ MAC" Two-Lumen Central Venous Access Kit Product Usage: The 2018-03-21
Class II — Some of the products listed in the recall may be missing a sticker that contains the lot number, expiration date, and Unique Device Identification (UDI) information.
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FDA Device Recall: Pressure Injectable Multi- Lumen Central Venous Pressure Injectable ARROW(R) PIC 2018-03-21
Class II — Some of the products listed in the recall may be missing a sticker that contains the lot number, expiration date, and Unique Device Identification (UDI) information.
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FDA Device Recall: Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter and 2018-03-21
Class II — Some of the products listed in the recall may be missing a sticker that contains the lot number, expiration date, and Unique Device Identification (UDI) information.
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FDA Device Recall: ARROWg+ard BLUE PLUS Pressure Injectable Quad- Lumen CVC Kit Product Usage: 2018-03-21
Class II — Some of the products listed in the recall may be missing a sticker that contains the lot number, expiration date, and Unique Device Identification (UDI) information.
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FDA Device Recall: ARROWg+ard Blue¿ Large-Bore Multi-Lumen CVC Kit Product Usage: The Arrow¿ CV 2018-03-21
Class II — Some of the products listed in the recall may be missing a sticker that contains the lot number, expiration date, and Unique Device Identification (UDI) information.
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FDA Device Recall: AGB+ Pressure Injectable Multi- Lumen CVC Kit Product Usage: The Arrow¿ CVC 2018-03-21
Class II — Some of the products listed in the recall may be missing a sticker that contains the lot number, expiration date, and Unique Device Identification (UDI) information.
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FDA Device Recall: ARROWg+ard Blue Product Usage: The Arrow¿ CVC is indicated to provide short- 2018-03-21
Class II — Some of the products listed in the recall may be missing a sticker that contains the lot number, expiration date, and Unique Device Identification (UDI) information.
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FDA Device Recall: Pressure Injectable Multi Lumen Central Venous Catheterization Kit with Blue Fl 2018-02-28
Class II — These finished good kits may contain the incorrect Springwire Guide (SWG).
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FDA Device Recall: ARROWg+ard Blue Plus Multi Lumen CVC (Central venous catheter); Product Code: AK 2018-02-28
Class II — These finished good kits may contain the incorrect Springwire Guide (SWG).
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FDA Device Recall: Arrow Multi Lumen CVC Kit (Central venous catheter); Product Code: CDC-15703-1A; 2018-02-28
Class II — These finished good kits may contain the incorrect Springwire Guide (SWG).
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FDA Device Recall: ARROWg+ard Blue Two Lumen Hemodialysis Catheterization Kit for High Volume Infus 2018-02-28
Class II — These finished good kits may contain the incorrect Springwire Guide (SWG).
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FDA Device Recall: Multi Lumen Central Venous Catheterization Kit; Product Code: ASK-12703-HH2; Ex 2018-02-28
Class II — These finished good kits may contain the incorrect Springwire Guide (SWG).
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FDA Device Recall: Central Venous Catheterization Kit with Blue FlexTip Catheter; Product code: AK- 2018-02-28
Class II — These finished good kits may contain the incorrect Springwire Guide (SWG).
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FDA Device Recall: Multi Lumen Central Venous Catheterization Kit with Blue FlexTip Catheter, Sharp 2018-02-28
Class II — These finished good kits may contain the incorrect Springwire Guide (SWG).
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FDA Device Recall: Pressure Injectable ARROWg+ard Blue PLUS Multi Lumen Central Venous Catheterizat 2018-02-28
Class II — These finished good kits may contain the incorrect Springwire Guide (SWG).
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FDA Device Recall: ARROW¿ PICC powered by ARROW¿ VPS¿ Stylet 2018-02-28
Class II — The kit may contain an incorrect catheter component. Kits that should contain a 40cm catheter may contain a 55cm catheter.
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FDA Device Recall: Multi Lumen Central Venous Catheterization Kit with Blue FlexTip Catheter and Sh 2018-02-28
Class II — These finished good kits may contain the incorrect Springwire Guide (SWG).
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FDA Device Recall: Radial Artery Catheterization Set, 1) NA-04550-1A & 2) NA-04550-X1A, device perm 2018-02-21
Class II — Needle supplier indicated the presence of loose polypropylene foreign matter above release specification.
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FDA Device Recall: ARROW PICC powered by ARROW VPS Stylet, Product Codes: CDC-35052-VPS and CDC-350 2018-02-21
Class II — Finished good kits may contain incorrect components. Kits that should contain a 5 FR 2 lumen catheter may contain a 4 FR single lumen catheter and kits that should contain a 4 FR single lum...
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FDA Recall: Arrow International Inc — Class II 20171206
There is a possibility that the finished good kits may contain 5 Fr peel-away sheaths instead of the required 4 Fr peel-away sheaths. | Product: ARROW¿ PICC powered by ARROW¿ VPS¿ Stylet The Pressure...
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FDA Recall: Arrow International Inc — Class II 20170719
Arrow is recalling additional lots that were identified as part of an active recall. Arrow is recalling the affected product due to the possibility th | Product: Arrow EVOLUTION Pressure Injectable PI...
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FDA Recall: Arrow International Inc — Class II 20170621
The Arrow Pressure Injectable PICC is intended for short-term or long-term peripheral access to the central venous system for intravenous therapy and | Product: Arrow Pressure Injectable PICC Kit Ca...
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FDA Recall: Arrow International Inc — Class II 20170614
Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packag | Product: Arrow Pressure Injectable PICC Kit Th...
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FDA Recall: Arrow International Inc — Class II 20170614
Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packag | Product: Pressure Injectable ARROW(R) PICC Kit ...
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FDA Recall: Arrow International Inc — Class II 20170614
Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packag | Product: Two-Lumen Hemodialysis Catheterization...
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FDA Recall: Arrow International Inc — Class II 20170614
Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packag | Product: AGB+ Pressure Injectable Multi-Lumen C...
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FDA Recall: Arrow International Inc — Class II 20170614
Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packag | Product: ARROWg+ard Blue MAC Two-Lumen Central ...
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FDA Recall: Arrow International Inc — Class II 20170614
Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packag | Product: ARROWg+ard Blue(R) MAC(TM) Two-Lumen C...
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FDA Recall: Arrow International Inc — Class II 20170614
Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packag | Product: Arrow(R) VPS(R) Access Kit for use wit...
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FDA Recall: Arrow International Inc — Class II 20170614
Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packag | Product: Pressure Injectable Multi-Lumen Centra...
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FDA Recall: Arrow International Inc — Class II 20170614
Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packag | Product: Radial Artery Catheterization Kit with...
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FDA Recall: Arrow International Inc — Class II 20170614
Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packag | Product: Pressure Injectable Multi-Lumen Centra...
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FDA Recall: Arrow International Inc — Class II 20170614
Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packag | Product: Arrow¿ VPS¿ Access Kit with Maximal Ba...
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FDA Device Recall: ARROW¿ PICC powered by ARROW¿ VPS¿ Stylet The Pressure Injectable PICC is indic 2017-12-06
Class II — There is a possibility that the finished good kits may contain 5 Fr peel-away sheaths instead of the required 4 Fr peel-away sheaths.
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FDA Device Recall: ARROW¿ PICC powered by ARROW¿ VPS¿ Stylet The Pressure Injectable PICC is indic 2017-12-06
Class II — There is a possibility that the finished good kits may contain 5 Fr peel-away sheaths instead of the required 4 Fr peel-away sheaths.
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FDA Device Recall: ArrowADVANTAGE5" Pressure Injectable Peripherally Inserted Central Catheter (PIC 2017-12-06
Class II — There is a possibility that the finished good kits may contain 5 Fr peel-away sheaths instead of the required 4 Fr peel-away sheaths.
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FDA Device Recall: Arrow EVOLUTION Pressure Injectable PICC with Chlorag+ard Antimicrobial and Anti 2017-07-19
Class II — Arrow is recalling additional lots that were identified as part of an active recall. Arrow is recalling the affected product due to the possibility that the catheter peel-away component hub...
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FDA Device Recall: Arrow Glide Thru Peel-Away Sheath/Dilator Introducer 2017-07-19
Class II — Arrow is recalling additional lots that were identified as part of an active recall. Arrow is recalling the affected product due to the possibility that the catheter peel-away component hub...
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FDA Device Recall: Arrow Pressure Injectable PICC Kit Catheter, Intravascular, Therapeutic, Long-T 2017-06-21
Class II — The Arrow Pressure Injectable PICC is intended for short-term or long-term peripheral access to the central venous system for intravenous therapy and blood sampling.
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FDA Device Recall: 1) Introducer Kit with Integral Hemostasis Valve/Side Port, Sharps Safety Featur 2017-06-21
Class II — Arrow International is recalling the affected product because the packaging may not be completely sealed, which may compromise sterility.
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FDA Device Recall: Arterial Catheterization Kit, Arterial Line Kit with Sharps Safety Features w 2017-06-21
Class II — Arrow International is recalling the affected product because the packaging may not be completely sealed, which may compromise sterility.
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FDA Device Recall: 1) Pressure Injectable ARROW(R) PICC Kit with Chlorag+ard(R) Technology The Pre 2017-06-21
Class II — Arrow International is recalling the affected product because the packaging may not be completely sealed, which may compromise sterility.
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FDA Device Recall: 1) Pressure Injectable Multi-Lumen Central Venous Catheterization Kit 2) Pressu 2017-06-21
Class II — Arrow International is recalling the affected product because the packaging may not be completely sealed, which may compromise sterility.
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FDA Device Recall: Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard 2017-06-21
Class II — Arrow International is recalling the affected product because the packaging may not be completely sealed, which may compromise sterility.
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FDA Device Recall: Single-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter, C 2017-06-21
Class II — Arrow International is recalling the affected product because the packaging may not be completely sealed, which may compromise sterility.
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FDA Device Recall: 1) ARROWg+ard Blue MAC Two-Lumen Central Venous Access Kit 2) ARROWg+ard Blue P 2017-06-21
Class II — Arrow International is recalling the affected product because the packaging may not be completely sealed, which may compromise sterility.
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FDA Device Recall: 1) ARROWg+ard Blue You-Blend Two-Lumen Hemodialysis Catheterization Kit for High 2017-06-21
Class II — Arrow International is recalling the affected product because the packaging may not be completely sealed, which may compromise sterility.
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FDA Device Recall: Arrow Pressure Injectable PICC Kit The Arrow International Pressure Injectable 2017-06-14
Class II — Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow products.
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FDA Device Recall: Pressure Injectable ARROW(R) PICC Kit with Chlorag+ard(R) Technology The Arro 2017-06-14
Class II — Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow products.
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FDA Device Recall: Two-Lumen Hemodialysis Catheterization Kit with Blue Flex Tip(R), ARROWg+ard Blu 2017-06-14
Class II — Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow products.
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FDA Device Recall: AGB+ Pressure Injectable Multi-Lumen CVC Kit The Arrow Central Venous Catheters 2017-06-14
Class II — Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow products.
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FDA Device Recall: ARROWg+ard Blue MAC Two-Lumen Central Venous Access Kit. The MAC Two-Lumen Cent 2017-06-14
Class II — Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow products.
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FDA Device Recall: ARROWg+ard Blue(R) MAC(TM) Two-Lumen Central Venous Access Kit for use with 7.5 2017-06-14
Class II — Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow products.
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FDA Device Recall: Arrow(R) VPS(R) Access Kit for use with 5 Fr. Peripherally Inserted Central Veno 2017-06-14
Class II — Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow products.
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FDA Device Recall: Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue Fle 2017-06-14
Class II — Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow products.
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FDA Device Recall: Radial Artery Catheterization Kit with Sharps Safety Features The Arrow¿ Arteri 2017-06-14
Class II — Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow products.
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FDA Device Recall: Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue Fle 2017-06-14
Class II — Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow products.
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FDA Device Recall: Arrow¿ VPS¿ Access Kit with Maximal Barrier Precautions for use with 4 Fr. Perip 2017-06-14
Class II — Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow products.
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FDA Device Recall: Pressure injectable Jugular Axillo-Subclavian Central CThe CG+Arrow JACC powered 2017-06-14
Class II — Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow products.
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FDA Device Recall: Arrow PICC with Chlorag+ard Technology The ArrowEVOLUTION Pressure Injectable P 2017-06-14
Class II — Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow products.
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FDA Device Recall: Arrow Pressure Injectable PICC Kit The Arrow International Pressure Injectabl 2017-06-14
Class II — Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow products.
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FDA Device Recall: Arrow Pressure Injectable PICC Kit The Arrow International Pressure Injectable 2017-06-14
Class II — Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow products.
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FDA Device Recall: Pressure Injectable ARROW(R) PICC Kit with Chlorag+ard(R) Technology The ArrowE 2017-06-14
Class II — Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow products.
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FDA Device Recall: Arterial Line Kit with Sharps Safety Features and Maximal Barrier Precautions T 2017-06-14
Class II — Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow products.
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FDA Device Recall: Arrow¿ Access Kit with Maximal Barrier Precautions for use with 4 Fr. Peripheral 2017-06-14
Class II — Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow products.
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FDA Device Recall: ARROWg+ard Blue PLUS(R) Two-Lumen Central Venous Catheterization Kit. The Arrow 2017-06-14
Class II — Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow products.
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FDA Device Recall: Arrow VPS Access Kit with Maximal Barrier Precautions for use with 5 Fr. Periphe 2017-06-14
Class II — Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow products.
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FDA Device Recall: AGB+ Pressure Injectable Multi-Lumen CVC Kit intended to permit venous access t 2017-06-14
Class II — Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow products.
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FDA Device Recall: QuickFlash Radial Artery/Arterial Line Catheterization Kit The Arrow¿ Arterial 2017-06-14
Class II — Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow products.
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FDA Device Recall: ARROWg+ard Blue You-Bend Two-Lumen Hemodialysis Catheterization Kit for High Vol 2017-06-14
Class II — The large-bore two-lumen catheter permits venous access to the central circulation for rapid fluid administration, temporary or acute hemodialysis, apheresis and hemofiltration. It may be i...
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FDA Device Recall: Arrow Pressure Injectable PICC Kit The Arrow International Pressure Injectable 2017-06-14
Class II — Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow products.
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FDA Device Recall: ARROWg+ard Blue PLUS(R) Two-Lumen Central Venous Catheterization Kit The Arrow( 2017-06-14
Class II — Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow products.
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FDA Device Recall: ARROWg+ard Blue Large-Bore Multi-Lumen CVC Kit The large-bore multiple-lumen 2017-06-14
Class II — Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow products.
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FDA Device Recall: Two-Lumen Hemodialysis Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue 2017-06-14
Class II — The large-bore two-lumen catheter permits venous access to the central circulation for rapid fluid administration, temporary or acute hemodialysis, apheresis and hemofiltration. It may be i...
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FDA Device Recall: ARROWg+ard Blue You-Bend Two-Lumen Hemodialysis Catheterization Kit for High Vol 2017-06-14
Class II — The large-bore two-lumen catheter permits venous access to the central circulation for rapid fluid administration, temporary or acute hemodialysis, apheresis and hemofiltration. It may be i...
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FDA Device Recall: Arrow PICC with Chlorag+ard Technology A PICC permits venous access to the cent 2017-06-14
Class II — Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow products.
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FDA Device Recall: Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port for 2017-06-14
Class II — Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow products.
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FDA Device Recall: Pressure Injectable Two-Lumen Central Venous Catheterization Kit with Blue FlexT 2017-06-14
Class II — Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow products.
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FDA Device Recall: ARROWg+ard Blue Large-Bore Multi-Lumen CVC Kit The large-bore multiple-lumen ca 2017-06-14
Class II — Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow products.
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FDA Device Recall: MAC(TM) Two-Lumen Central Venous Access Kit with ARROWg+ard Blue(R) Access Devic 2017-06-14
Class II — Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow products.
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FDA Device Recall: Pressure Injectable Quad-Lumen Central Venous Catheterization Kit with Blue Flex 2017-06-14
Class II — Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow products.
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FDA Device Recall: ARROWg+ard Blue Large-Bore Multi-Lumen CVC Kit. The large-bore multiple-lumen c 2017-06-14
Class II — Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow products.
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FDA Device Recall: MAC(TM) Two-Lumen Central Venous Access Kit with ARROWg+ard Blue (R) Access Devi 2017-06-14
Class II — Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow products.
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FDA Device Recall: Arrow¿ Access Kit with Maximal Barrier Precautions for use with 5 Fr. Peripheral 2017-06-14
Class II — Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow products.
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FDA Device Recall: Arrow PICC with Chlorag+ard Technology A PICC permits venous access to the cent 2017-06-14
Class II — Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow products.
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FDA Device Recall: QuickFlash(R) Radial Artery/Arterial Line Catheterization Kit The Arrow¿ Arteri 2017-06-14
Class II — Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow products.
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FDA Device Recall: Femoral Arterial Line Catheterization Kit The Arrow¿ Arterial Catheterization d 2017-06-14
Class II — Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow products.
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FDA Device Recall: Percutaneous Sheath Introducer Kit with ARROWg+ard Blue(R) Sheath, Integral Hemo 2017-06-14
Class II — Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow products.
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FDA Device Recall: Pressure Injectable ARROWg+ard Blue PLUS(R) Two-Lumen Central Venous Catheteriza 2017-06-14
Class II — Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow products.
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FDA Device Recall: Arrow¿ VPS¿ Access Kit with Maximal Barrier Precautions for use with 5 Fr. Perip 2017-06-14
Class II — Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow products.
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FDA Device Recall: Arrow(R) Access Kit for use with 4 Fr. Peripherally Inserted Central Venous Cath 2017-06-14
Class II — Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow products.
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FDA Device Recall: Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue Fle 2017-06-14
Class II — Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow products.
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FDA Device Recall: Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue Fle 2017-06-14
Class II — Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow products.
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FDA Device Recall: Pressure Injectable Arrowg+ard Blue Plus Multi-Lumen Central Venous Catheterizat 2017-05-03
Class II — Arrow International is recalling due to possible voids in the catheter hub, which could lead to an interlumen crossover.
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FDA Device Recall: The CG+ Arrow PIC Catheters permit venous access to the central circulation thro 2017-04-12
Class II — Arrow International, Inc. notified its customers who received the affected Antimicrobial/Antithrombogenic PICC Kits, that the kits were being recalled due to a labeling error. The lidstock ...
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FDA Device Recall: HANDS-OFF Infusion Port Thermodilution Catheter consists of the Arrow IPTD therm 2016-11-09
Class II — Labeling inconsistency
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FDA Device Recall: Walrus Arterial Embolectomy Catheter The arterial embolectomy catheter is int 2016-10-12
Class II — Arrow is recalling due to incorrect labeling of products.
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FDA Device Recall: Cather, Ultrasound, Intravascular The VPS Stylet and Console are indicated fo 2016-09-21
Class II — Notification of component molding abnormality by supplier used to package certain Arrow Select Kit (ASK) products.
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FDA Device Recall: Catheter, Intravascular, Therapeutic, Long Term Greater than 30 days. An acce 2016-09-21
Class II — Notification of component molding abnormality by supplier used to package certain Arrow Select Kit (ASK) products.
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FDA Device Recall: Catheter, Percutaneous The Arrow Single-Lumen Catheter permits venous access 2016-09-21
Class II — Notification of component molding abnormality by supplier used to package certain Arrow Select Kit (ASK) products.
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FDA Device Recall: Radial Artery Catheterization Kit with Sharps Safety Features Permits access to 2016-09-14
Class II — Shipping carton labeling error.
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FDA Device Recall: Arterial Line Catheterization Kit with Sharps Safety Features Permits access to 2016-09-14
Class II — Shipping carton labeling error.
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FDA Device Recall: Femoral Arterial Line Catheterization Kit with Sharps Safety Features 510K 810 2016-07-20
Class II — Labeling error. Some shipping cartons labeled as ASK-04018-VUH contained ASK-04020-VUH kits; and some shipping cartons labeled as ASK-04020-VUH contained ASK-04018-VUH kits.
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FDA Device Recall: Femoral Arterial Line Catheterization Kit with Sharps Safety Features 510K 810 2016-07-20
Class II — Labeling error. Some shipping cartons labeled as ASK-04018-VUH contained ASK-04020-VUH kits; and some shipping cartons labeled as ASK-04020-VUH contained ASK-04018-VUH kits.
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FDA Device Recall: ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE CENTRAL VENOUS CA 2016-07-13
Class II — Arrow is recalling these products due to the possibility that although the kit is labeled as containing a 20 cm catheter, a 16 cm catheter may be packaged in the kit.
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FDA Recall: Arrow International Inc — Class II 20150128
the Instructions for Use (IFU) were inadvertently removed from the kit. | Product: Multi-Lumen PI CVC Kit and PSI Kit: 3-L 7 FR X 8 product code: ASK-45703-POSU lot #23F13L0166, exp.
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FDA Recall: Arrow International Inc — Class II 20150128
The tunneling sheath packaged within the kits can crack during placement. If the tunneling sheath cracks, it can cause a delay in treatment for the t | Product: The Arrow Edge Hemodialysis Catheteriz...
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FDA Device Recall: Arrow Intra-Aortic Balloon Catheter Kit Fiberoptix (IAB), 8 Fr 40 cc Model: 2015-03-18
Class II — Potential for a leak between the catheter and the bifurcate which would allow helium to escape to the atmosphere.
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FDA Device Recall: ARROW Epidural Needle Component (product number AN-05501). Epidural needles per 2015-02-18
Class II — The product labeling does not specify the 5 year shelf life of the product.
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FDA Device Recall: ARROWg+ard Blue PLUS Pressure Injectable Two-Lumen CVC Kit. The Multiple-Lumen C 2015-02-18
Class II — Foreign material found within the kits. The foreign material, white or black particles and/or thread, is visible and can beidentified by the user.
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FDA Device Recall: Arrow Select Kits (ASK), Maximal Barrier Precautions Kits (CDC) and Arterial Cat 2015-02-04
Class III — Certain product codes and lot numbers of Kits with Biopatch Dressing were packaged with the incorrect size Biopatch Dressing. No risk to patients is anticipated.
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FDA Device Recall: Multi-Lumen PI CVC Kit and PSI Kit: 3-L 7 FR X 8 product code: ASK-45703-POSU l 2015-01-28
Class II — the Instructions for Use (IFU) were inadvertently removed from the kit.
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FDA Device Recall: The Arrow Edge Hemodialysis Catheterization Set Long-Term Access and NextStep An 2015-01-28
Class II — The tunneling sheath packaged within the kits can crack during placement. If the tunneling sheath cracks, it can cause a delay in treatment for the time it takes to retrieve a replacement ...
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FDA Recall: Arrow International Inc — Class II 20141029
Arrow International, Inc. is notifying customers that lot 23F13K0969 of product code ASK-05501-AFH1 contains an incorrect component. The lidstock indi | Product: ASK-05501-AFH1, Lot Number 23F13K0969 ...
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FDA Device Recall: Arrow Nerve Block Component, Product Code: AB-18040-N: Permits placement of cath 2014-12-17
Class II — Arrow is recalling certain lots of the Continuous Nerve Block Component, Product Code: AB-18040-N, due to a labeling inconsistency. The product lidstock incorrectly identifies the needle...
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FDA Device Recall: ASK-05501-AFH1, Lot Number 23F13K0969 Anesthesia Conduction Catheter, Epidural A 2014-10-29
Class II — Arrow International, Inc. is notifying customers that lot 23F13K0969 of product code ASK-05501-AFH1 contains an incorrect component. The lidstock indicates that the kit contains one Syring...
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FDA Device Recall: Multi-Lumen Central Venous Catheterization Kit 2014-10-22
Class II — Arrow International, Inc. has initiated a voluntary recall for product code AK- 12703, lot number RF3039028 because the label on the outer corrugate is labeled with the incorrect expiratio...
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FDA Device Recall: Arrow Select Kits (ASK) and Maximal Barrier Precautions Kits (CDC) with BD Medic 2014-10-22
Class II — The component supplier recalled their 0.9% Sodium Chloride Injection USP BD Posiflush SF Saline Flush Syringe 10mL because some unit packages may exhibit open seals which impact package int...
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FDA Device Recall: Arrowgard Blue and Arrowgard Blue Plus Pressure Injectable Central Venous Cathet 2014-05-28
Class II — The labeling states that the kit contains Introducer Needle: Echogenic 18 Ga. x 2.5 (6.35cm) XTW and 5mL ArroW Raulerson Spring-Wire Introduction Syringe; however, the kit contains, and sh...
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FDA Device Recall: Arrow Pressure Injectable PICC Powered by Arrow VPS Stylet Catalogue number CDC- 2014-04-30
Class II — Kits are packaged with the incorrect catheter. The kits contain a 40cm catheter and should contain a 50cm catheter.
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FDA Device Recall: Arrowgard Blue Plus Antimicrobial Multi-lumen Central Venous Catheter, catalogue 2014-04-30
Class II — Arrow is recalling the Arrowgard Blue Plus Antimicrobial Multi-lumen Central Venous Catheter due to a labeling inconsistency. One portion of the lidstock states that the kit contains 8.5FR...
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FDA Device Recall: Continuous Peripheral Nerve Block Catheter Kit and Set Continuous Peripheral 2013-12-25
Class II — A labeling inconsistency was discovered in which the lidstock states that the kit contains a stimulator cable with 1.5mm socket, however, the kit contains a stimulator cable with 1.5mm pin.
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FDA Device Recall: Arrow Transradial Artery Access products Arrow Transradial Artery Access prod 2013-12-18
Class II — There is a risk that the introducer needles packaged within the kits can be partially or fully occluded, which can cause delayed treatment or an adverse event when used on a patient.
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FDA Device Recall: Arrow International, Inc. Two-Lumen CVC Kit with Blue Flex Tip Catheter. The mul 2013-08-21
Class II — Arrow is recalling the product due to a labeling inconsistency. One portion of the lidstock states the kit contains a 3-Lumen catheter while the rest of the lidstock correctly identifies th...
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FDA Device Recall: Arrow International FiberOptix Intra-Aortic Balloon Catheter Kit (IAB) 8 Fr 30 2013-04-17
Class II — Potential to have an internal leak at the fill port of the stainless steel tip, which may necessitate removal and replacement of the catheter.
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FDA Device Recall: Arrow/Teleflex Medical Berman Angiographic Balloon Catheter and Reverse Berman A 2013-04-10
Class II — The product specifications sheet, part of the Instructions for Use (IFU), for the specified product numbers, reference Renografin-76 contrast medium (viscosity of 8.4 centipoise), which is ...
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FDA Device Recall: Arrow Two-Lumen Central Venous Catheterization Set with Blue FlexTip(R) ARROWgar 2012-07-04
Class I — Lidstock of product does not contain chlorhexidine contraindication and contains wording "contains no medication" on the label. Product insert does reflect medicated status.
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irs_exempt 1 records
IRS Exempt: ARROW
501(c)(3) Charitable — WASHINGTON, DC — NTEE: Q30
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nppes 1 records
NPI Provider: ARROW
NPI: 1962370767 | TX
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ny_corps 8 records
NY Corp: ARROW ASSOCIATES HOLDINGS LLC 2025-09-24
FOREIGN LIMITED LIABILITY COMPANY | County: Monroe | Jurisdiction: New Mexico
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NY Corp: ARROW HOLDINGS, LLC 2008-02-19
DOMESTIC LIMITED LIABILITY COMPANY | County: Tompkins | Jurisdiction: New York
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NY Corp: ARROW GROUP LLC 2004-06-24
DOMESTIC LIMITED LIABILITY COMPANY | County: Onondaga | Jurisdiction: New York
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NY Corp: ARROW LLC 2003-07-30
DOMESTIC LIMITED LIABILITY COMPANY | County: Westchester | Jurisdiction: New York
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NY Corp: ARROW PARTNERS LP 2002-12-19
FOREIGN LIMITED PARTNERSHIP | County: New York | Jurisdiction: Delaware
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NY Corp: ARROW PARTNERS, INC. 1995-06-21
DOMESTIC BUSINESS CORPORATION | County: New York | Jurisdiction: New York
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NY Corp: ARROW INTERNATIONAL, INC. 1989-06-29
FOREIGN BUSINESS CORPORATION | County: New York | Jurisdiction: Ohio
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NY Corp: ARROW ASSOCIATES, L.P. 1984-07-05
FOREIGN LIMITED PARTNERSHIP | County: | Jurisdiction: Delaware
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OSHA 1 records
OSHA Inspection (Complaint) - Arrow Co 1982-04-21
OSHA inspection at Arrow Co, Atlanta, GA. NAICS: 000000. SIC: 2321
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