Device product
CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-103.
Z-0480-2025
Product summary
- Firm
- Caire, Inc.
- Event
- Event 95576
- Status
- Completed
- Classification
- Class II
- Quantity
- 6 concentrators
- Official record key
device-enforcement:Z-0480-2025
Official wording
Reason: Potential failure of affected units to recharge the battery of the oxygen concentrators.
Code information: No UDI-DI (for export only); Serial numbers CBB5224350751, CBB5224350720, CBB5224350604, CBB5224350601, CBB5224350598, and CBB5224350582.
Distribution pattern: Worldwide distribution - US Nationwide, including PR and the countries of Israel and Peru.
Derived failure modes
-
Unknown
Potential failure of affected units to recharge the battery of the oxygen concentrators.