medical Class III Updated 2022-07-20

Invacare Corporation recalls Invacare Platinum 5NXG Oxygen Concentrator, Model Numbers P5

Recalled Product

Invacare Platinum 5NXG Oxygen Concentrator, Model Numbers P5NXG1, P5NXGC1 (Canada specific model)


Hazard / Issue

Between March 2, 2021 and December 31, 2021, the product label used in production did not contain the "Rx Only" statement as required.

Issued by

FDA

Distribution: 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
Lot/Code Info: UDI-DI: 00841447112075 Serial Number Prefixes: 21FEXXXXXX 21JEXXXXXX 21GEXXXXXX 21KEXXXXXX 21HEXXXXXX 21LEXXXXXX 21IEXXXXXX
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