Urgent recall notice for the ARROW QuickFlash Line Catheterization Kits

Urgent Recall Notice for ARROW QuickFlash Catheterization Kits 

In February 2024, Teleflex and its subsidiary Arrow International issued an urgent recall notice for the ARROW QuickFlash Radial Artery and Radial Artery/Arterial Line Catheterization Kits.  

Today, a recall notice was posted on the FDA website. 

The action comes in response to reports indicating increased resistance in the guidewire handle and chamber during use, potentially leading to serious injuries or even fatalities. 

The U.S. Food and Drug Administration (FDA) has classified this recall as Class I, the most severe type, due to the significant risks involved. 

Recalled Product Details 

Product Name: ARROW QuickFlash Radial Artery and Radial Artery/Arterial Line Catheterization Kits 

Product Codes: Refer to the Recall Database Entry 

Units Affected in the U.S.: 334,995 

Distribution Dates: December 1, 2021, to January 27, 2024 

Initiation Date: February 12, 2024 

Reason for Recall 

The recall stems from reports of increased resistance in the device’s guidewire handle and chamber during use. Such resistance poses a grave risk, potentially resulting in injuries such as damage to blood vessel walls, vasospasm, artery blockage, or, in severe cases, even death. Teleflex/Arrow International have received 194 complaints, with 10 injuries and one fatality linked to this issue. 

Action Required 

If you have used or distributed the affected products, it is crucial to take immediate action: 

Medical Facilities 

• Check your inventory for the recalled product. 
• Cease using and distributing affected items. 
• Quarantine the recalled products. 
• Complete the acknowledgment form included in the Urgent Medical Device Recall letter and send it to Teleflex via fax or email. 
• Await further instructions regarding product return. 

Distributors 

• Distribute copies of the recall letter to all impacted customers. 
• Ensure that customers complete and return the acknowledgment form. 
• Halt distribution and use of the affected products. 
• Quarantine and return the recalled items. 
• Confirm completion of field activities with Teleflex. 

Contact Information 

For any inquiries or assistance related to this recall, please contact Teleflex and Arrow International Customer Service: 

• Phone: 1-866-396-2111 
• FAX: 1-855-419-8507 
• Email: Recalls@teleflex.com 

Conclusion 

Prompt attention to this matter is critical for patient safety and regulatory compliance. Take the necessary steps outlined in the recall notice to mitigate risks and ensure the well-being of patients. Stay informed and proactive in addressing this issue to prevent any potential harm. 

Read the full recall announcement here.