Z-0805-2020 Class II Terminated
FDA device recall Z-0805-2020 was initiated by Caire, Inc. on November 21, 2019 and is designated Class II. Reason for recall: Four units of European version FreeStyle Comfort were distributed in the US, but were not cleared for use in the US.. The recall status is terminated (terminated November 20, 2020). Affected quantity: 4 units.
Recall Details
- Product Type
- Devices
- Report Date
- January 22, 2020
- Initiation Date
- November 21, 2019
- Termination Date
- November 20, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4 units
Product 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 for Recall
Four units of European version FreeStyle Comfort were distributed in the US, but were not cleared for use in the US..
Distribution Pattern
US Nationwide distribution in the states of MI, CA, CT.
Code Information
Serial Numbers: CBB5219310254, CBB5219310255, CBB5219310279, CBB5219310280