Recall Z-1117-2022 ยท CAW Generator, Oxygen, Portable
Caire, Inc.
CAIRE FreeStyle Comfort Portable Oxygen Concentrator with autoSAT, UltraSense and autoDOSE, model #AS200-3
| Date | Mar 25, 2022 |
| Status | Terminated |
| Reason | The device was not cleared for U.S. distribution. |
| Root cause | No Marketing Application |
| Action | The recalling firm initially contacted the customer via voicemail and email on 3/25/2022. The email informed the consignee that the two affected units that were shipped to them could not be sold in the U.S. or its territories due to FDA approval. The email requested the consignee confirm their address so that call tags could be sent to them for return of the affected units. The consignee was informed the units will be replaced with the new AS200-1 units as soon as the recalled units are returned. The model and serial numbers were provided of the affected units. The voicemail message summa |
| Quantity | 2 oxygen concentrators |
| Distribution | Distribution was made to Puerto Rico. There was no foreign/government/military distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.