Recall Z-0805-2020— Caire, Inc.
Class II · Terminated
Class II FDA medical device recall by Caire, Inc., initiated 2019-11-21, terminated 2020-11-20. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: Four units of European version FreeStyle Comfort were distributed in the US, but were not cleared for use in the US...
- Recalling firm
- Caire, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-11-21
- Terminated
- 2020-11-20
- Firm location
- Ball Ground, GA, United States
Product description
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.
Reason for recall
Four units of European version FreeStyle Comfort were distributed in the US, but were not cleared for use in the US..
Data sourced from openFDA. This site is unofficial and independent of the FDA.