BEUDAMED
    FDA Enforcement Class II Ongoing

    Molift 2-Point sling bar, an accessory for Molift Mover 180/Air. Item nos. 1830001 1830002 1830002C 1830003

    Recall: Z-1352-2019 · Reported May 22, 2019

    Enforcement

    Recall Number
    Z-1352-2019
    Event ID
    81977
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Moller Vital
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    May 22, 2019
    Initiation Date
    February 4, 2019
    Classification Date
    May 16, 2019
    Address
    Hadelandsvegen 2, P.o. Box 408, Gjovik, N/A, Norway

    Description

    Molift 2-Point sling bar, an accessory for Molift Mover 180/Air. Item nos. 1830001 1830002 1830002C 1830003

    Reason

    The firm has received 7 reports of malfunction for the device in which the hooks have broken off, potentially leading the sling to slip out of the sling bar and causing the patient to fall.

    Code Info

    All units manufactured between May 2013 and October 2018. Date of manufacture is labeled on the product.

    Distribution

    Domestic distribution to Arizona, Delaware, Florida, Georgia, Massachusetts, Ohio, South Carolina, Texas, Washington, and Wisconsin. Foreign distribution to Canada, Asia, Europe, and Australia.

    Quantity

    427 (total)