BEUDAMED
    FDA Enforcement Class III Ongoing

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

    Recall: Z-1369-2022 · Reported July 20, 2022

    Enforcement

    Recall Number
    Z-1369-2022
    Event ID
    90108
    Classification
    Class III
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Invacare Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 20, 2022
    Initiation Date
    June 10, 2022
    Classification Date
    July 12, 2022
    Address
    1200 Taylor St, Elyria, OH, 44035-6248, United States

    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.

    Code Info

    UDI-DI: 00841447112075 Serial Number Prefixes: 21FEXXXXXX 21JEXXXXXX 21GEXXXXXX 21KEXXXXXX 21HEXXXXXX 21LEXXXXXX 21IEXXXXXX

    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