CAIRE MODEL: FreeStyle Comfort Oxygen Concentrator recall
CAIRE MODEL: FreeStyle Comfort Oxygen Concentrator - Product Usage: The FreeStyle Comfort Oxygen Concentrator is intended for the administration of…
Why was CAIRE MODEL: FreeStyle Comfort Oxygen Concentrator recalled?
Four units of European version FreeStyle Comfort were distributed in the US, but were not cleared for use in the US..
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: CBB5219310254, CBB5219310255, CBB5219310279, CBB5219310280
- Product
- CAIRE MODEL: FreeStyle Comfort Oxygen Concentrator - Product Usage: The FreeStyle Comfort Oxygen Concentrator is intended for the administration of…
- Recalling firm
- Caire, Inc.
- Quantity
- 4 units
- Distribution
- US Nationwide distribution in the states of MI, CA, CT.
- Recall date
- January 22, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)