BEUDAMED
    FDA Enforcement Class II Terminated

    Assist Bed Rail - 6632

    Recall: Z-2218-2017 · Reported June 7, 2017

    Enforcement

    Recall Number
    Z-2218-2017
    Event ID
    77128
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Invacare Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 7, 2017
    Initiation Date
    April 25, 2017
    Classification Date
    June 1, 2017
    Termination Date
    January 16, 2018
    Address
    1200 Taylor St, Elyria, OH, 44035-6248, United States

    Description

    Assist Bed Rail - 6632

    Reason

    A typographical error was noted within the user manual for the 6632 Assist Bed Rail which could result in the Assist Bed Rails being installed incorrectly.

    Code Info

    MN: 6632; Date Code begging with FT150701 through FT170228

    Distribution

    Product was shipped to all US states plus the District of Columbia. Product was also shipped to Canada and Australia.

    Quantity

    5,020 Units