FDA Enforcement
Class II
Completed
CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-2.
Recall: Z-0481-2025
·
Reported November 27, 2024
Enforcement
- Recall Number
- Z-0481-2025
- Event ID
- 95576
- Classification
- Class II
- Status
- Completed
- Product Type
- Devices
- Firm
- Caire, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- November 27, 2024
- Initiation Date
- October 4, 2024
- Classification Date
- November 15, 2024
- Address
- 2200 Airport Industrial Dr Ste 500, N/A, Ball Ground, GA, 30107-4686, United States
Description
CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-2.
Reason
Potential failure of affected units to recharge the battery of the oxygen concentrators.
Code Info
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
Worldwide distribution - US Nationwide, including PR and the countries of Israel and Peru.
Quantity
26 concentrators