Teleflex is recalling the Arrow QuickFlash Radial Artery and Radial Artery/Arterial Line Catheterization Kits after receiving reports of increased resistance in the guidewire handle and chamber during use. This issue may cause serious injury, including injury to blood vessel walls, nArrowing of the blood vessels (vasospasm), artery blockage (embolism), or death.
Arrow QuickFlash Radial Artery and Radial Artery/Arterial Line Catheterization Kits allow healthcare providers access to a patient’s peripheral arterial circulation or other small vessels.
Teleflex, and their subsidiary Arrow International sent an Urgent Medical Device Recall letter to customers that included the following recommended actions:
- Check inventory for product within the scope of this recall.
- Stop using and distributing affected product.
- Quarantine affected product.
- Mark the applicable checkbox (affected product or no affected product) on the acknowledgement form included with the letter. Fax the form to 1-855-419-8507 to Attn: Customer Service or email the form to [email protected].
- If you have affected product, a customer service representative will contact you with a Return Goods Authorization (RGA) number and will provide instructions for the return of affected products to Teleflex. Teleflex (or the local dealer) will issue a credit note upon receipt of the returned affected product.
- Ensure you only list batch numbers in scope of the recall notice when completing the form.
Teleflex/Arrow International reports 194 complaints. A total of 10 injuries, and one death have been reported related to this issue.The FDA has identified this as a class I recall, the most serious type of recall, meaning that use of these devices may cause serious injuries or death.