Recall Z-0481-2025— Caire, Inc.
Class II · Completed
Class II FDA medical device recall by Caire, Inc., initiated 2024-10-04. FDA's recall record names no specific 510(k) clearance for this event. Product: CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-2.. Reason: Potential failure of affected units to recharge the battery of the oxygen concentrators..
- Recalling firm
- Caire, Inc.
- Classification
- Class II
- Status
- Completed
- Initiated
- 2024-10-04
- Firm location
- Ball Ground, GA, United States
Product description
CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-2.
Reason for recall
Potential failure of affected units to recharge the battery of the oxygen concentrators.
Data sourced from openFDA. This site is unofficial and independent of the FDA.