Teleflex and its subsidiary Arrow International have recalled the Arrow QuickFlash radial artery and radial artery/arterial line catheterization kits over a potentially defective component.
The company has received reports of increased resistance in the guidewire handle and chamber during use, which could cause arterial vasospasm and vessel injury arising from multiple arterial punctures with repeated attempts.
The US Food and Drug Administration (FDA) has identified this as a Class I recall, the most serious type, due to the risk for serious injury or death.
To date, the manufacturer has received 194 reports, including a total of 10 injuries and one death related to this issue.
The recall includes 334,995 kits distributed in the United States between December 1, 2021 and January 27, 2024. Details on product codes are available in the FDA recall database.
On February 12, 2024, Teleflex and Arrow International sent an urgent medical device recall letter to affected customers them to identify and quarantine any recalled kits, and complete and return the acknowledgement form by fax (1-855-419-8507 Attn: Customer Service) or email (recalls@teleflex.com).
Customers with any recalled kits will be contacted by a customer service representative who will provide a return goods authorization (RGA) number and instructions for returning the product.
Questions about this recall can be directed to Teleflex and Arrow International Customer Service at 1-866-396-2111.