FDANovember 7, 2022device

Flow-c Anesthesia System (Product Code 6887700) Flow-e Anesthesia System (Product Code 6887900)

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

The hazard

The power backup battery, under certain conditions, may exhibit reduced battery run-time while in use, and there is a potential that the battery may fail to provide the expected run time in the event of a mains power failure. This could require the clinician to use manual emergency ventilation of another ventilator is not available and the backup battery is exhausted.

What to do

FDA enforcement status: Ongoing

Brands named

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UPCs

73257100104577325710009765

Recall history

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

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