Reported May 25, 2022 · Terminated
CAIRE FreeStyle Comfort Portable Oxygen Concentrator with autoSAT, UltraSense and autoDOSE, model #AS200-3
Caire, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Caire, Inc. · 2200 Airport Industrial Dr Ste 500 · Ball Ground, GA · 30107-4686
Is this the product you have?
- CAIRE FreeStyle Comfort Portable Oxygen Concentrator with autoSAT, UltraSense and autoDOSE, model #AS200-3
- Lot codes and dates
- Serial numbers CBB5221200337 and CBB5221200287.
- Amount recalled
- 2 oxygen concentrators
Where it was sold
Why it was recalled
The device was not cleared for U.S. distribution.
This product could cause temporary or reversible health problems — stop using it.
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