FDA Recall
Terminated
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.
Recall: Z-0805-2020
·
Initiated November 21, 2019
Recall
- Recall Number
- Z-0805-2020
- Event Number
- 84512
- Firm
- Caire, Inc.
- FEI Number
- 3004972304
- Product Code
- CAW
- Status
- Terminated
- Root Cause
- Packaging process control
- Initiated
- November 21, 2019
- Terminated
- November 20, 2020
- Address
- 2200 Airport Industrial Dr, Ste 500, Ball Ground, GA, 30107-4686
Description
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.
Reason
Four units of European version FreeStyle Comfort were distributed in the US, but were not cleared for use in the US..
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.
Distribution
US Nationwide distribution in the states of MI, CA, CT.
Quantity
4 units