Device 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.
Z-0805-2020
Product summary
- Firm
- Caire, Inc.
- Event
- Event 84512
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4 units
- Official record key
device-enforcement:Z-0805-2020
Official wording
Reason: Four units of European version FreeStyle Comfort were distributed in the US, but were not cleared for use in the US..
Code information: Serial Numbers: CBB5219310254, CBB5219310255, CBB5219310279, CBB5219310280
Distribution pattern: US Nationwide distribution in the states of MI, CA, CT.
Derived failure modes
-
Unknown
Four units of European version FreeStyle Comfort were distributed in the US, but were not cleared for use in the US..