CAIRE FreeStyle Comfort Portable Oxygen Concentrator with autoSAT, UltraSense and autoDOSE, model #AS200-3
This recall has been terminated (originally issued March 25, 2022).
- Company
- Caire, Inc.
- Recall Initiated
- March 25, 2022
- Terminated
- October 5, 2023
- Recall Number
- Z-1117-2022
- Quantity
- 2 oxygen concentrators
- Firm Location
- Ball Ground, GA
- Official Source
- View on FDA website ↗
Reason for Recall
The device was not cleared for U.S. distribution.
Distribution
Distribution was made to Puerto Rico. There was no foreign/government/military distribution.
Lot / Code Info
Serial numbers CBB5221200337 and CBB5221200287.
Root Cause
No Marketing Application
Action Taken
The recalling firm initially contacted the customer via voicemail and email on 3/25/2022. The email informed the consignee that the two affected units that were shipped to them could not be sold in the U.S. or its territories due to FDA approval. The email requested the consignee confirm their address so that call tags could be sent to them for return of the affected units. The consignee was informed the units will be replaced with the new AS200-1 units as soon as the recalled units are returned. The model and serial numbers were provided of the affected units. The voicemail message summarized the information that was in the email.