Reported Aug 5, 2015 · Terminated
OxySure Model 615 disposable replacement cartridges, for portable oxygen generator.
Oxysure Systems, 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: Oxysure Systems, Inc. · 10880 John W Elliott Dr Ste 600 · Frisco, TX · 75033-3281
Is this the product you have?
- OxySure Model 615 disposable replacement cartridges, for portable oxygen generator.
- Lot codes and dates
- lots 61-65
- Amount recalled
- 1005 units
Where it was sold
- Nationwide
Why it was recalled
Flow rate of the recalled replacement cartridges does not meet the draft FDA standard of a minimum 6 LPM for a minimum of 15 minutes.
This product could cause temporary or reversible health problems — stop using it.
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