Teleflex and Arrow International Recall ARROW QuickFlash Radial Artery and Radial Artery/Arterial Line Catheterization Kits for Increased Resistance That May Lead to Vessel Injuries, Narrowing, or Blockage

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 recalls@teleflex.com. 
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 recalls@teleflex.com.
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.
Contact Information 

Customers with questions should contact Teleflex and Arrow International Customer Service: Phone: 1-866-396-2111FAX: 1-855-419-8507Email: Recalls@teleflex.com 

Additional Resources 

How do I report a problem?

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX.

 

Content current as of:
04/03/2024