FDA announces Class I recall of nearly 2,000 catheter kits
The U.S. Food and Drug Administration (FDA) has announced that Arrow International, a subsidiary of Teleflex, is recalling nearly 2,000 Pressure Injectable Catheter Kits. The FDA considered this a Class I recall, which means using these devices “may cause serious injuries or death.”
Arrow International’s Pressure Injectable Catheter Kits provide short-term access—typically less than 30 days—to a patient’s central cardiovascular system. This assists clinicians with making frequent blood draws, intravenous therapy infusion, frequent blood sampling, and pressure injection of imaging contrast media.
This recall is due to a mislabeling issue; the device is coated in chlorhexidine, but the product code and product name both suggest there is no such coating. The packaging's banner card contains the correct information (see the image below).
“People who inadvertently use these kits may have serious adverse health effects, such as allergic reactions including itching, redness, skin changes, hives, dizziness, drop in blood pressure, difficulty breathing, and anaphylaxis which could lead to death if they are allergic to chlorohexidine,” according to the FDA’s advisory.
The recall includes 1,905 devices distributed to customers from August 2022 to June 2023. A total of sixteen incidents have been reported due to this ongoing issue, but there are no reports of injuries or deaths.
Product codes/lots impacted by this recall include:
- CDC-05541-HPK1A/143F22J0617
- CDC-35552-VPS/13F22EO359
- CDC-42854-XPCN1A/33F23B0723
- CDC-45552-VPS2/33F23B0781
- CDC-45854-P1A/13F22L0806
- CDC-45563-TTS/13F22G0508
What medical facilities and distributors should do if impacted by the FDA’s recall of these Pressure Injectable Catheter Kits
Teleflex and Arrow International sent an Urgent Medical Device Recall letter to medical facilities and distributors.
According to that letter, medical facilities should stop using any devices included in this recall. Also, the devices should be quarantined to ensure they are not accidentally used for patient care. Distributors, meanwhile, are advised to “immediately stop” sending out these devices. They should also provide a copy of the Urgent Medical Device Recall letter to all impacted customers.
Prior Teleflex/Arrow International recalls
In June 2023, Teleflex and Arrow International recalled more than 250,000 catheters due to device separation and leakage. At the time, the issue was associated with 83 customer complaints and 18 patient injuries.
In December 2022, the companies recalled more than 2,000 intra-aortic balloon pumps due to significant battery issues. There were 241 customer complaints about this issue, including 135 reported pump stops, but no patient injuries.
Also, Teleflex recalled a percutaneous thrombolytic device in December 2021 due to issues with its inner lumen detaching while in use.
Michael has more than 18 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.