FDA issues early alert for microbore extension sets

Editor's Note

B Braun Medical is recommending certain microbore extension sets—single use, disposable, add-ons for infusion, injection, or aspiration—be removed from anywhere they are used or sold, according to a July 17 announcement from the US Food and Drug Administration (FDA).

According to FDA’s early alert, the recall was motivated by incorrect information. “Specifically, the product label shows that the device contains an air eliminating filter. However, the filter used on this extension set does not feature an air vent, which is common to air eliminating filters, and is not indicated for the removal of air,” the agency reports.

Risks include filter occlusion and resulting delayed therapy or embolization, which can cause serious injury or death. No serious injuries or deaths had been reported as of July 9. Instructions, identifying information, and other details are included in the full FDA announcement. 

FDA also recently announced two Class 1 recalls—the most severe category indicating risk of serious injury or death—for Dexcom’s continuous glucose monitor receivers and Drive DeVilbiss Healthcare’s DV6X-619 DC Car Adapter, which is used with iGo2 Portable Oxygen Concentrator Systems.