The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
Recalled Product
- Product Name: ARROW QuickFlash Radial Artery and Radial Artery/Arterial Line Catheterization Kits
- Product Codes: See Recall Database Entry
- Devices Recalled in the U.S.: 334,995
- Dates Distributed: December 1, 2021 to January 27, 2024
- Date Initiated by Firm: February 12, 2024
Device Use
The ARROW QuickFlash Radial Artery and Radial Artery/Arterial Line Catheterization Kits allow health care providers access to a patient’s peripheral arterial circulation or other small vessels.
Reason for Recall
Teleflex, and their subsidiary Arrow International, are 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.
Teleflex/Arrow International reports 194 complaints. A total of 10 injuries, and one death have been reported related to this issue.
Who May Be Affected
- People who receive care with the ARROW QuickFlash Radial Artery and Radial Artery/Arterial Line Catheterization Kits.
What to Do
On February 12, 2024, Teleflex and Arrow International sent an Urgent Medical Device Recall letter to customers that included the following recommended actions:
For Medical Facilities
- Immediately:
- 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.
For Distributors
- Provide a copy of the Urgent Medical Device Recall letter to all customers who have received impacted product. Each customer must complete the acknowledgement form and return it to the distributor.
- Immediately:
- Check inventory for product within the scope of this recall.
- Stop using and distributing affected product.
- Quarantine affected product.
- Return all product in scope.
- Confirm to Teleflex that field activities outlined have been completed.
- After completing actions, forward the completed acknowledgement form to [email protected].
- Ensure you only list batch numbers in scope of the recall notice when completing the form.
- If product was distributed outside of the country, notify Teleflex Customer Service.
FDA has more information.
