Recall Z-0480-2025
Caire, Inc. · initiated October 4, 2024
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-103.
Codes / lots: No UDI-DI (for export only); Serial numbers CBB5224350751, CBB5224350720, CBB5224350604, CBB5224350601, CBB5224350598, and CBB5224350582.
Reason for recall
Potential failure of affected units to recharge the battery of the oxygen concentrators.
FDA-determined 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.
Details
- Recall number
- Z-0480-2025
- Initiated
- October 4, 2024
- Posted by FDA
- November 15, 2024
- Product code
- CAW – Generator, Oxygen, Portable
- Quantity
- 6 concentrators
- Distribution
- Worldwide distribution - US Nationwide, including PR and the countries of Israel and Peru.
- Recalling firm
- Caire, Inc., Ball Ground, GA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0478-2025 Class II | CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-1.Potential failure of affected units to recharge the battery of the oxygen concentrators. | 10/04/2024Completed |
| Z-0479-2025 Class II | CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-101.Potential failure of affected units to recharge the battery of the oxygen concentrators. | 10/04/2024Completed |
| Z-0481-2025 Class II | CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-2.Potential failure of affected units to recharge the battery of the oxygen concentrators. | 10/04/2024Completed |