CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-101.
This recall is currently active, issued November 15, 2024. It was issued by Caire, Inc..
- Company
- Caire, Inc.
- Recall Initiated
- October 4, 2024
- Posted
- November 15, 2024
- Recall Number
- Z-0479-2025
- Quantity
- 23 concentrators
- Firm Location
- Ball Ground, GA
- Official Source
- View on FDA website ↗
Reason for Recall
Potential failure of affected units to recharge the battery of the oxygen concentrators.
Distribution
Worldwide distribution - US Nationwide, including PR and the countries of Israel and Peru.
Lot / Code Info
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.
Root Cause
Nonconforming Material/Component
Action Taken
The recalling firm issued letters via email on and dated 10/4/2024 to their "sold-to" DME (durable medical equipment) distributors. The letter explained the reason for recall, identified the affected serial numbers and when they were shipped to the DME distributor, and requested the devices be returned to the recalling firm immediately. They are informed the devices will be replaced with new or repaired units. The DME distributor is to contact the CAIRE Customer Service via phone or email to arrange for return of the devices. A Response Form: Acknowledgement of Receipt was enclosed to indicate they have read and understand the recall instructions.