CAIRE FreeStyle Comfort Portable Oxygen Concentrator recall
CAIRE FreeStyle Comfort Portable Oxygen Concentrator with autoSAT, UltraSense and autoDOSE, model #AS200-3
Why was CAIRE FreeStyle Comfort Portable Oxygen Concentrator recalled?
The device was not cleared for U.S. distribution.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Serial numbers CBB5221200337 and CBB5221200287.
- Product
- CAIRE FreeStyle Comfort Portable Oxygen Concentrator with autoSAT, UltraSense and autoDOSE, model #AS200-3
- Recalling firm
- Caire, Inc.
- Quantity
- 2 oxygen concentrators
- Distribution
- Distribution was made to Puerto Rico. There was no foreign/government/military distribution.
- Recall date
- May 25, 2022
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)