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_echo
2 records
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
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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 ...
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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 ...
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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 ...
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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 ...
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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 ...
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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 ...
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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
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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..
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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: Epidural Needle; Product Codes: AN-05501 and AN-05505
2018-06-06
Class II — Product sterility may be compromised due to unsealed packaging.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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: 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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
View Source
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.
View Source
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.
View Source
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.
View Source
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.
View Source
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.
View Source
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.
View Source
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.
View Source
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.
View Source
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.
View Source
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.
View Source
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.
View Source
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.
View Source
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.
View Source
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.
View Source
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.
View Source
FDA Device Recall: Pneumothorax Kit
2018-04-11
Class II — Product packaging may not be completely sealed.
View Source
FDA Device Recall: Large Volume Abdominal Paracentesis Kit
2018-04-11
Class II — Product packaging may not be completely sealed.
View Source
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.
View Source
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...
View Source
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...
View Source
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...
View Source
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.
View Source
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.
View Source
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.
View Source
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.
View Source
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.
View Source
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.
View Source
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.
View Source
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.
View Source
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).
View Source
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).
View Source
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).
View Source
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).
View Source
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).
View Source
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).
View Source
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).
View Source
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).
View Source
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.
View Source
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).
View Source
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.
View Source
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...
View Source
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...
View Source
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...
View Source
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...
View Source
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...
View Source
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 ...
View Source
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...
View Source
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...
View Source
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 ...
View Source
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...
View Source
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...
View Source
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...
View Source
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...
View Source
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...
View Source
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...
View Source
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.
View Source
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.
View Source
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.
View Source
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...
View Source
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...
View Source
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.
View Source
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.
View Source
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.
View Source
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.
View Source
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.
View Source
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.
View Source
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.
View Source
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.
View Source
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.
View Source
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.
View Source
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.
View Source
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.
View Source
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.
View Source
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.
View Source
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.
View Source
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.
View Source
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.
View Source
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.
View Source
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.
View Source
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.
View Source
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.
View Source
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.
View Source
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.
View Source
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.
View Source
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.
View Source
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.
View Source
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.
View Source
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.
View Source
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.
View Source
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.
View Source
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.
View Source
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...
View Source
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.
View Source
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.
View Source
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.
View Source
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...
View Source
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...
View Source
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.
View Source
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.
View Source
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.
View Source
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.
View Source
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.
View Source
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.
View Source
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.
View Source
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.
View Source
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.
View Source
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.
View Source
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
nppes
1 records
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
View Source
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
View Source
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