BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-1369-2022 · Initiated June 10, 2022

    Recall

    Recall Number
    Z-1369-2022
    Event Number
    90108
    Firm
    Invacare Corporation
    FEI Number
    1525712
    Product Code
    CAW
    Status
    Open, Classified
    Root Cause
    Labeling Change Control
    Initiated
    June 10, 2022
    Address
    1200 Taylor St, Elyria, OH, 44035-6248

    Description

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

    Reason

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

    Action

    On June 10, 2022, the firm distributed Medical Device Correction letters to affected providers. Providers were informed that they may have received product with an incorrect label which does not contain the required "Rx Only" symbol. Providers were provided with Provider Acknowledgement Cards which included instructions for applying the correct product label to the device. Providers are responsible for ensuring that the field correction is conducted with their customers. If you have any questions concerning these instructions, please call Invacare's field correction support line at (877) 413-6008 (U.S. Customers) Monday thru Friday, 8 a.m. 5 p.m. EST, for assistance.

    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

    Quantity

    179 devices