FDANovember 21, 2019device
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.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Four units of European version FreeStyle Comfort were distributed in the US, but were not cleared for use in the US..
What to do
FDA enforcement status: Terminated
Brands named
caire
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDACAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-2.2024-10-04
- FDACAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-101.2024-10-04
- FDACAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-1.2024-10-04
- FDACAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-103.2024-10-04
- FDACAIRE Liberator 20, MODEL 13256195, Liquid Oxygen System Unit2022-10-10
- FDACAIRE Liberator 30, MODEL 13337403, Liquid Oxygen System Unit2022-10-10
- FDACAIRE Liberator 45, MODEL 13261699, Liquid Oxygen System Unit2022-10-10
- FDACAIRE Liberator 45, MODEL 13262253, Liquid Oxygen System Unit2022-10-10
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