BEUDAMED
    FDA Enforcement Class II Terminated

    ReTurn 7500/7500 Aid, transfer

    Recall: Z-0303-2017 · Reported November 2, 2016

    Enforcement

    Recall Number
    Z-0303-2017
    Event ID
    75404
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Handicare USA, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 2, 2016
    Initiation Date
    April 15, 2014
    Classification Date
    October 24, 2016
    Termination Date
    December 13, 2016
    Address
    2201 Hangar Pl, Ste 200, Allentown, PA, 18109-9342, United States

    Description

    ReTurn 7500/7500 Aid, transfer

    Reason

    During the period of April 2009  May 2011, Handicare AB used a wing handle in which the screw and handle, after repeated tightening, may slide apart. This causes a small amount of play in the attachment of the ladder, which in turn results in high load at the attachment holes of the ladder. Eventually, this may cause mechanical fatigue in the material of the ladder.

    Code Info

    Model # 7400, 7500 and 7322 (spare part) Serial # 373317697270501334, 373317697270501430, 073317697400500012, 073317697400500057

    Distribution

    US Distribution to the states of : NY, NJ, NV, NE, IL, CT, PA and ME

    Quantity

    29 units , plus 47 wing handles were shipped as spare parts