ARROW INTERNATIONAL

Reports have been received regarding open seals on the packaging.

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: -failure of the intra-aortic balloon to completely inflate over its full length -damaged or broken central lumen in the segment contained within the balloon -helium loss or blood in the helium pathway.

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: -failure of the intra-aortic balloon to completely inflate over its full length -damaged or broken central lumen in the segment contained within the balloon -helium loss or blood in the helium pathway.

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: -failure of the intra-aortic balloon to completely inflate over its full length -damaged or broken central lumen in the segment contained within the balloon -helium loss or blood in the helium pathway.

Teleflex is initiating this voluntary recall for the above-mentioned products due to reports received indicating a potentially defective component. The complaints received relate to resistance of the guidewire handle/chamber during use. The possible immediate health consequences of the component issue are arterial vasospasm and vessel injury arising from multiple arterial punctures with repeated attempts.

This recall has been initiated due to reports that the product code and product name were incorrectly listed on the lidstock of affected kits.

This recall has been initiated due to reports that the product code and product name were incorrectly listed on the lidstock of affected kits.

This recall has been initiated due to reports that the product code and product name were incorrectly listed on the lidstock of affected kits.

This recall has been initiated due to reports that the product code and product name were incorrectly listed on the lidstock of affected kits.

This recall has been initiated due to reports that the product code and product name were incorrectly listed on the lidstock of affected kits.

This recall has been initiated due to reports that the product code and product name were incorrectly listed on the lidstock of affected kits.

Potential for catheter separation or leakage

There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.

There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.

There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.

There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.

There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.

There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.

There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.

There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.

There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.

There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.

There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.

There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.

There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.

There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.

There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.

There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.

There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.

There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.

There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.

There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.

There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.

There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.

There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.

There is the potential for inadequate connection between the top and bottom housings of the Micro Clave Clear Connectors included in the Arrow MAC Two-Lumen Central Venous Access Kit and the Arrow Pressure Injectable Arrowg+ard Blue Plus Three-Lumen CVC Kit.

There is the potential for inadequate connection between the top and bottom housings of the Micro Clave Clear Connectors included in the Arrow MAC Two-Lumen Central Venous Access Kit and the Arrow Pressure Injectable Arrowg+ard Blue Plus Three-Lumen CVC Kit.

There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.

There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.

There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.

There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.

There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.

There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.

There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.

There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.

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 volumes and kit contents for product code ASK-41552-JHVA1), instead of the packaged single-lumen 4.5 French catheter (and related priming volumes and kit contents for product code ASK-41541-JHVA1).

Gravity flow rates on the affected product lidstock are incorrect.

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 therapy.

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 therapy.

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 therapy.

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 therapy.

Marketed without a 510K

Marketed without a 510K

Marketed without a 510K

Marketed without a 510K

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 repeat biopsy, leading to a prolonged procedure

The lidstock / information card on the kits correctly states the product code as CDC-45703-1A. The banner card on the side of the kit may incorrectly state the product code as CDC-15703-1A and not identify the product as a coated ARROWg+ard Blue PLUS (AGB+) antimicrobial catheter which may cause a minor delay during use and placement of a coated catheter in patients with known sensitivity to chlorohexidine, silver sulfadiazine or sulfa could result in an allergic reaction

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 or other complications. Sterility, biocompatibility, safety, or efficacy of the kits and their components are not assured beyond the correct expiration date.

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 or other complications. Sterility, biocompatibility, safety, or efficacy of the kits and their components are not assured beyond the correct expiration date.

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 or other complications. Sterility, biocompatibility, safety, or efficacy of the kits and their components are not assured beyond the correct expiration date.

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 or other complications. Sterility, biocompatibility, safety, or efficacy of the kits and their components are not assured beyond the correct expiration date.

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 resulting in fretting, charring, and discoloration of motor connector wires, which may result in pump alarms for System Error 3 and High Baseline presented on the screen of the IABP, and potential abrupt cessation of function or inability to start the IABP.

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 resulting in fretting, charring, and discoloration of motor connector wires, which may result in pump alarms for System Error 3 and High Baseline presented on the screen of the IABP, and potential abrupt cessation of function or inability to start the IABP.

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 resulting in fretting, charring, and discoloration of motor connector wires, which may result in pump alarms for System Error 3 and High Baseline presented on the screen of the IABP, and potential abrupt cessation of function or inability to start the IABP.

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 resulting in fretting, charring, and discoloration of motor connector wires, which may result in pump alarms for System Error 3 and High Baseline presented on the screen of the IABP, and potential abrupt cessation of function or inability to start the IABP.

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 resulting in fretting, charring, and discoloration of motor connector wires, which may result in pump alarms for System Error 3 and High Baseline presented on the screen of the IABP, and potential abrupt cessation of function or inability to start the IABP.

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 resulting in fretting, charring, and discoloration of motor connector wires, which may result in pump alarms for System Error 3 and High Baseline presented on the screen of the IABP, and potential abrupt cessation of function or inability to start the IABP.

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 resulting in fretting, charring, and discoloration of motor connector wires, which may result in pump alarms for System Error 3 and High Baseline presented on the screen of the IABP, and potential abrupt cessation of function or inability to start the IABP.

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 resulting in fretting, charring, and discoloration of motor connector wires, which may result in pump alarms for System Error 3 and High Baseline presented on the screen of the IABP, and potential abrupt cessation of function or inability to start the IABP.

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 resulting in fretting, charring, and discoloration of motor connector wires, which may result in pump alarms for System Error 3 and High Baseline presented on the screen of the IABP, and potential abrupt cessation of function or inability to start the IABP.

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 resulting in fretting, charring, and discoloration of motor connector wires, which may result in pump alarms for System Error 3 and High Baseline presented on the screen of the IABP, and potential abrupt cessation of function or inability to start the IABP.

Nine complaints reported that the rotatable collar on the filter had detached, causing a leak.

Product lidstock contains the incorrect expiration date for the product

Product lidstock contains the incorrect expiration date for the product

Product lidstock contains the incorrect expiration date for the product

Product lidstock contains the incorrect expiration date for the product

Product lidstock contains the incorrect expiration date for the product

Product lidstock contains the incorrect expiration date for the product

Product lidstock contains the incorrect expiration date for the product

Product lidstock contains the incorrect expiration date for the product

Product lidstock contains the incorrect expiration date for the product

Product lidstock contains the incorrect expiration date for the product

Product lidstock contains the incorrect expiration date for the product

Product lidstock contains the incorrect expiration date for the product

Product lidstock contains the incorrect expiration date for the product

Product lidstock contains the incorrect expiration date for the product

Product lidstock contains the incorrect expiration date for the product

Product lidstock contains the incorrect expiration date for the product

Product lidstock contains the incorrect expiration date for the product

Product lidstock contains the incorrect expiration date for the product

Product lidstock contains the incorrect expiration date for the product

Product lidstock contains the incorrect expiration date for the product

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.

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.

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.

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.

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.

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.

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.

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.