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FDADecember 18, 2020device

ALung Technologies Hemolung Respiratory Assist System (RAS) with CME BodyGuard 323 Infusion Pump(EUA) - Product Usage: an off-the-shelf infusion pump and administration set to provide a 30 mL/hr continuous saline flush to the integrated blood pump bearing.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

CME America BodyGuard 323 Infusion Pumps (recalled by manufacturer) is a component to the Hemolung for EUA, and the infusion pump may have a delivery inaccuracy

What to do

FDA enforcement status: Terminated

Brands named

alung technologiesalung

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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