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Caire, Inc. recalls CAIRE MODEL: FreeStyle Comfort Oxygen Concentrator - Product Usage: The FreeStyle Comfort Oxygen Concentrator is intende
Recalled January 22, 2020 · FDA recall Z-0805-2020 · Caire
Hazard
Four units of European version FreeStyle Comfort were distributed in the US, but were not cleared for use in the US.. · FDA Class II
Units
4 units
Sold at
US Nationwide distribution in the states of MI, CA, CT.
Description
Four units of European version FreeStyle Comfort were distributed in the US, but were not cleared for use in the US..
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.
Manufacturer(s)
Caire, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →