Device product
CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-101.
Z-0479-2025
Product summary
- Firm
- Caire, Inc.
- Event
- Event 95576
- Status
- Completed
- Classification
- Class II
- Quantity
- 23 concentrators
- Official record key
device-enforcement:Z-0479-2025
Official wording
Reason: Potential failure of affected units to recharge the battery of the oxygen concentrators.
Code information: UDI-DI: M766AS2001010; Serial numbers: CBB5224380888, CBB5224380868, CBB5224380846, CBB5224380842, CBB5224380298, CBB5224380295, CBB5224380282, CBB5224380251, CBB5224380011, CBB5224380010, CBB5224370651, CBB5224370598, CBB5224370445, CBB5224370431, CBB5224370420, CBB5224370230, CBB5224370227, CBB5224370191, CBB5224370185, CBB5224370168, CBB5224370165, CBB5224370009, and CBB5224350790.
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.