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Invacare Corporation recalls Invacare Platinum 5NXG Oxygen Concentrator, Model Numbers P5NXG1, P5NXGC1 (Canada specific model)
Recalled July 20, 2022 · FDA recall Z-1369-2022 · Invacare
Hazard
Between March 2, 2021 and December 31, 2021, the product label used in production did not contain the "Rx Only" statement as required. · FDA Class III
Units
179 devices
Sold at
Domestic distribution to the following states: ALASKA ARIZONA CALIFORNIA COLORADO GEORGIA IDAHO IOWA KANSAS KENTUCKY MICHIGAN MINNESOTA MISSOURI NEW YORK NORTH CAROLINA OHIO OKLAHOMA PENNSYLVANIA TENNESSEE
Description
Between March 2, 2021 and December 31, 2021, the product label used in production did not contain the "Rx Only" statement as required.
Product
Invacare Platinum 5NXG Oxygen Concentrator, Model Numbers P5NXG1, P5NXGC1 (Canada specific model)
Manufacturer(s)
Invacare Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →