medical Class II Updated 2020-01-22

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

Distribution: Nationwide (United States)
Lot/Code Info: Serial Numbers: CBB5219310254, CBB5219310255, CBB5219310279, CBB5219310280
View official government recall

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