Alung Technologies Inc recalls ALung Technologies Hemolung Respiratory Assist System (RAS) with CME BodyGuard 323 Infusion Pump(EUA) - Product Usage:…

Recall date

December 18, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0938-2021

FDA classification

Class II

Brand / firm

Alung Technologies Inc

Sold / distributed

US Nationwide distribution.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.