Recall Z-1117-2022— Caire, Inc.
Class II · Terminated
Class II FDA medical device recall by Caire, Inc., initiated 2022-03-25, terminated 2023-10-05. FDA's recall record names no specific 510(k) clearance for this event. Product: CAIRE FreeStyle Comfort Portable Oxygen Concentrator with autoSAT, UltraSense and autoDOSE, model #AS200-3. Reason: The device was not cleared for U.S. distribution..
- Recalling firm
- Caire, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2022-03-25
- Terminated
- 2023-10-05
- Firm location
- Ball Ground, GA, United States
Product description
CAIRE FreeStyle Comfort Portable Oxygen Concentrator with autoSAT, UltraSense and autoDOSE, model #AS200-3
Reason for recall
The device was not cleared for U.S. distribution.
Data sourced from openFDA. This site is unofficial and independent of the FDA.