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Caire, Inc. recalls CAIRE FreeStyle Comfort Portable Oxygen Concentrator with autoSAT, UltraSense and autoDOSE, model #AS200-3
Recalled May 25, 2022 · FDA recall Z-1117-2022 · Caire
Hazard
The device was not cleared for U.S. distribution. · FDA Class II
Units
2 oxygen concentrators
Sold at
Distribution was made to Puerto Rico. There was no foreign/government/military distribution.
Description
The device was not cleared for U.S. distribution.
Product
CAIRE FreeStyle Comfort Portable Oxygen Concentrator with autoSAT, UltraSense and autoDOSE, model #AS200-3
Manufacturer(s)
Caire, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →