Recall Z-0805-2020 ยท CAW Generator, Oxygen, Portable
Caire, Inc.
CAIRE MODEL: FreeStyle Comfort Oxygen Concentrator - Product Usage: The FreeStyle Comfort Oxygen Concentrator is intended for the administration of supplemental oxygen. The device is not intended for life support nor does it provide any patient monitoring capabilities.
| Date | Nov 21, 2019 |
| Status | Terminated |
| Reason | Four units of European version FreeStyle Comfort were distributed in the US, but were not cleared for use in the US.. |
| Root cause | Packaging process control |
| Action | The firm initiated the recall by telephone and email on 11/19/2019, then followed with a letter on 12/04/2019. The firm requested the removal of all units and will exchange them for the US approved version. |
| Quantity | 4 units |
| Distribution | US Nationwide distribution in the states of MI, CA, CT. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.