FDA Issues Update on Teleflex Recall for Central Venous Catheter Kits

The FDA has deemed the Oct. 27 recall by Teleflex and subsidiary Arrow International of two central venous catheter kits as Class 1 because of the risk of serious injury or death.

The two products are the Arrow MAC two-lumen central venous access kit and the Arrowg+ard Blue Plus three-lumen central venous catheter kit. The affected devices were distributed between March 8 and May 13, 2022.

The recall was prompted by inadequate connectors in the kits that could cause bleeding, fluid leakage, delayed treatment, infection, air in the blood vessels and other serious injuries, the agency said.

The Arrow MAC kit is designed to permit venous access for less than 30 days and to introduce a catheter into the patient’s central circulation. The Arrowg+ard kit is designed to provide protection for less than 30 days against catheter-related bloodstream infections.

Teleflex and Arrow have not reported any injuries or death related to this issue.