Reported Jan 22, 2020 · Terminated
CAIRE MODEL: FreeStyle Comfort Oxygen Concentrator - Product Usage: The FreeStyle Comfort Oxygen Concentrator is…
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 MODELFreeStyle Comfort
- Oxygen Concentrator - Product UsageThe FreeStyle Comfort Oxygen Concentrator is intended for the administration of supplemental oxygen. The device is not intended for life support nor does it provide any patient monitoring capabilities
- Lot codes and dates
- Serial Numbers
CBB5219310254CBB5219310255CBB5219310279CBB5219310280
- Serial Numbers
- Amount recalled
- 4 units
Where it was sold
Why it was recalled
Four units of European version FreeStyle Comfort were distributed in the US, but were not cleared for use in the US..
This product could cause temporary or reversible health problems — stop using it.
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