Device product
CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-2.
Z-0481-2025
Product summary
- Firm
- Caire, Inc.
- Event
- Event 95576
- Status
- Completed
- Classification
- Class II
- Quantity
- 26 concentrators
- Official record key
device-enforcement:Z-0481-2025
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: CBB5224350777, CBB5224350774, CBB5224350743, CBB5224350723, CBB5224350710, CBB5224350653, CBB5224350648, CBB5224350636, CBB5224350606, CBB5224350583, CBB5224350580, CBB5224350575, CBB5224350573, CBB5224350567, CBB5224350512, CBB5224350510, CBB5224350509, CBB5224350508, CBB5224350498, CBB5224350492, CBB5224350490, CBB5224350475, CBB5224350474, CBB5224350468, CBB5224350460, and CBB5224350459.
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.