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
Four units of European version FreeStyle Comfort were distributed in the US, but were not cleared for use in the US..
What You Should Do
Remedy
The firm initiated the recall by telephone and email on 11/19/2019, then followed with a letter on 12/04/2019. The firm requested the removal of all units and will exchange them for the US approved version.
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Products
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
- Brand
- Caire, Inc.
- UPC
- Serial Numbers: CBB5219310254, CBB5219310255, CBB5219310279, CBB5219310280
Units Affected
4 units