Recall Z-1117-2022
Caire, Inc. · initiated March 25, 2022
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
CAIRE FreeStyle Comfort Portable Oxygen Concentrator with autoSAT, UltraSense and autoDOSE, model #AS200-3
Codes / lots: Serial numbers CBB5221200337 and CBB5221200287.
Reason for recall
The device was not cleared for U.S. distribution.
FDA-determined 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.
Details
- Recall number
- Z-1117-2022
- Initiated
- March 25, 2022
- Terminated
- October 5, 2023
- Product code
- CAW – Generator, Oxygen, Portable
- Quantity
- 2 oxygen concentrators
- Distribution
- Distribution was made to Puerto Rico. There was no foreign/government/military distribution.
- Recalling firm
- Caire, Inc., Ball Ground, GA