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FDAAugust 5, 2021device

AMSORB PLUS PREFILLED G-CAN 1.0L; Carbon dioxide absorbent canister; Product codes AMAB3801 and AMAB3801GE. Used in anesthesia.

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

The hazard

Some devices may be associated with high and unexpected resistance to gas flow during clinical use, impacting or preventing adequate ventilation of an anaesthetised patient, which could cause a delay in treatment. Not all defective canisters will be identified by the pre-use test.

What to do

FDA enforcement status: Terminated

Brands named

armstrong medical servicesarmstrongarmstrong medical

Recall history

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

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