Z-0480-2025 Class II
Recall Details
- Product Type
- Devices
- Report Date
- November 27, 2024
- Initiation Date
- October 4, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6 concentrators
Product Description
CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-103.
Reason for Recall
Potential failure of affected units to recharge the battery of the oxygen concentrators.
Distribution Pattern
Worldwide distribution - US Nationwide, including PR and the countries of Israel and Peru.
Code Information
No UDI-DI (for export only); Serial numbers CBB5224350751, CBB5224350720, CBB5224350604, CBB5224350601, CBB5224350598, and CBB5224350582.