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.
This recall has been terminated (originally issued November 21, 2019).
- Company
- Caire, Inc.
- Recall Initiated
- November 21, 2019
- Terminated
- November 20, 2020
- Recall Number
- Z-0805-2020
- Quantity
- 4 units
- Firm Location
- Ball Ground, GA
- Official Source
- View on FDA website ↗
Reason for Recall
Four units of European version FreeStyle Comfort were distributed in the US, but were not cleared for use in the US..
Distribution
US Nationwide distribution in the states of MI, CA, CT.
Lot / Code Info
Serial Numbers: CBB5219310254, CBB5219310255, CBB5219310279, CBB5219310280
Root Cause
Packaging process control
Action Taken
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.