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

Recall date

June 10, 2022

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1369-2022

FDA classification

Class III

Brand / firm

Invacare Corporation

Sold / distributed

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

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.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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