BEUDAMED
    FDA Enforcement Class II Terminated

    Handicare C Series Patient Lift Product Usage: A device used to lift and transport a patient from one place to another.

    Recall: Z-2752-2018 · Reported August 29, 2018

    Enforcement

    Recall Number
    Z-2752-2018
    Event ID
    80556
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Handicare Usa Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 29, 2018
    Initiation Date
    November 3, 2017
    Classification Date
    August 20, 2018
    Termination Date
    July 10, 2020
    Address
    10888 Metro Ct, Maryland Heights, MO, 63043-2413, United States

    Description

    Handicare C Series Patient Lift Product Usage: A device used to lift and transport a patient from one place to another.

    Reason

    Premature strap wear and breakage at maximum weight conditions (625 lbs.).

    Code Info

    Device Model; 323100, 323102, 323117, 323118, 323120, 323137, 323149, 323150, 323215, 323225, 323237, 323240, 323400, 323417, 323450, 323600, 323602, 323700, 323750, 323840, 323851, 323917, 323117V, and 323150V

    Distribution

    Worldwide Distribution - US Nationwide in the states of AK, CA, CT, DE, GA, IA, IL, KY, LA, MA, ME, MI, MN, MO, NE, NV, NY, OH, OR, PA, RI, TN, TX, WI, and Puerto Rico and the countries of Canada and Australia,

    Quantity

    716