Teleflex and Arrow International, LLC Recall Arrow MAC Two-Lumen Central Venous Access and Pressure Injectable Arrowg+ard Blue Plus Three-Lumen Central Venous Catheter (CVC) Kits
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 MAC Two-Lumen Central Venous Access Kits; Arrow Pressure Injectable Arrowg+ard Blue Plus Three-Lumen Central Venous Catheter (CVC) Kits
- Product Models: See Recall Database entry
- Distribution Dates: March 8, 2022 to May 13, 2022
- Devices Recalled in the U.S.: 1,355
- Date Initiated by Firm: October 27, 2022
Device Use
The Arrow MAC Two-Lumen Central Venous Access Kit is intended to permit short term (less than 30 days) venous access and catheter introduction to the central circulation.
The Arrow Pressure Injectable Arrowg+ard Blue Plus Three-Lumen CVC Kit is intended to provide short-term (less than 30 days) protection against catheter-related bloodstream infections. It is not intended to be used as a treatment for existing infections.
Reason for Recall
Teleflex and their subsidiary Arrow International, LLC are recalling the Arrow MAC Two-Lumen Central Venous Access Kits; Arrow Pressure Injectable Arrowg+ard Blue Plus Three-Lumen Central Venous Catheter (CVC) Kits for the risk of a cross-lumen leak caused by inadequate connections between the top and bottom housings of the Micro Clave Clear Connectors included in the kits.
Use of affected devices may cause bleeding, fluid leakage, delayed treatment, infection, air in the blood vessels (air embolism), other serious injuries or death.
Teleflex/Arrow International LLC has reported no injuries or deaths related to this issue.
Who May be Affected
- People who receive care using the Arrow MAC Two-Lumen Central Venous Access Kits; Arrow Pressure Injectable Arrowg+ard Blue Plus Three-Lumen Central Venous Catheter (CVC) Kits.
- Health care personnel providing care using the Arrow MAC Two-Lumen Central Venous Access Kits; Arrow Pressure Injectable Arrowg+ard Blue Plus Three-Lumen Central Venous Catheter (CVC) Kits.
- Distributors of the Arrow MAC Two-Lumen Central Venous Access Kits; Arrow Pressure Injectable Arrowg+ard Blue Plus Three-Lumen Central Venous Catheter (CVC) Kits.
What to Do
On October 27, 2022, Teleflex and Arrow International, LLC sent customers an Urgent Medical Device Recall letter. The letter recommended the following actions:
- Stop using and distributing affected products.
- Return affected products to Teleflex Inc. (Arrow International’s parent company) for a refund.
Contact Information
Customers with questions should call Teleflex customer service at 866-396-2111 or email 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.