BEUDAMED
    FDA Enforcement Class II Terminated

    ReTurn belt, wipeable, sizes Small through Extra Large, Plastic pouch, 1 item per pouch. Patient transfer aid.

    Recall: Z-1613-2015 · Reported May 20, 2015

    Enforcement

    Recall Number
    Z-1613-2015
    Event ID
    70995
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Handicare USA, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 20, 2015
    Initiation Date
    March 26, 2015
    Classification Date
    May 14, 2015
    Termination Date
    August 17, 2015
    Address
    2201 Hangar Pl, Ste 200, Allentown, PA, 18109-9342, United States

    Description

    ReTurn belt, wipeable, sizes Small through Extra Large, Plastic pouch, 1 item per pouch. Patient transfer aid.

    Reason

    Complaints were received that the heat-welded seam on the wipeable belt's strap tore when force was applied.

    Code Info

    All affected product in the U.S are from the same LOT #1402S, Model #s 6133-6136

    Distribution

    US Distribution to the states of : FL, CA, NJ, NC and MD.

    Quantity

    64