Reported Jul 20, 2022 · Ongoing
Invacare Platinum 5NXG Oxygen Concentrator, Model Numbers P5NXG1, P5NXGC1 (Canada specific model)
Invacare Corporation
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.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: Invacare Corporation · 1200 Taylor St · Elyria, OH · 44035-6248
Is this the product you have?
Invacare Platinum 5NXG Oxygen ConcentratorModel Numbers P5NXG1P5NXGC1 (Canada specific model)
- Lot codes and dates
- UDI-DI00841447112075
- Serial Number Prefixes21FEXXXXXX 21JEXXXXXX 21GEXXXXXX 21KEXXXXXX 21HEXXXXXX 21LEXXXXXX 21IEXXXXXX
- Amount recalled
- 179 devices
Where it was sold
Why it was recalled
Between March 2, 2021 and December 31, 2021, the product label used in production did not contain the "Rx Only" statement as required.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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