Recall Z-0478-2025 ยท CAW Generator, Oxygen, Portable
Caire, Inc.
CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-1.
| Date | Nov 15, 2024 (initiated Oct 4, 2024) |
| Status | Completed |
| Reason | Potential failure of affected units to recharge the battery of the oxygen concentrators. |
| Root cause | Nonconforming Material/Component |
| Action | 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 indi |
| Quantity | 739 concentrators |
| Distribution | Worldwide distribution - US Nationwide, including PR and the countries of Israel and Peru. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K020324 | LIFESTYLE OXYGEN CONCENTRATOR Airsep Corp., Mar 13, 2002 |