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.