Caire, Inc. recalls CAIRE MODEL: FreeStyle Comfort Oxygen Concentrator - Product
Recalled Product
CAIRE MODEL: FreeStyle Comfort Oxygen Concentrator - Product Usage: The FreeStyle Comfort Oxygen Concentrator is intended for the administration of supplemental oxygen. The device is not intended for life support nor does it provide any patient monitoring capabilities.
Hazard / Issue
Four units of European version FreeStyle Comfort were distributed in the US, but were not cleared for use in the US..
Issued by
FDA
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