Z-1117-2022 Class II Terminated
FDA device recall Z-1117-2022 was initiated by Caire, Inc. on March 25, 2022 and is designated Class II. Reason for recall: The device was not cleared for U.S. distribution. The recall status is terminated (terminated October 5, 2023). Affected quantity: 2 oxygen concentrators.
Recall Details
- Product Type
- Devices
- Report Date
- May 25, 2022
- Initiation Date
- March 25, 2022
- Termination Date
- October 5, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2 oxygen concentrators
Product Description
CAIRE FreeStyle Comfort Portable Oxygen Concentrator with autoSAT, UltraSense and autoDOSE, model #AS200-3
Reason for Recall
The device was not cleared for U.S. distribution.
Distribution Pattern
Distribution was made to Puerto Rico. There was no foreign/government/military distribution.
Code Information
Serial numbers CBB5221200337 and CBB5221200287.