BEUDAMED
    FDA Enforcement Class III Terminated

    DePuy LifeLiner Stick & Cut Resistant Gloves Rt, Lg Part No. 5200-68-000 The gloves are designed to resist sticks and cuts and are not cut or puncture proof. These gloves are not required by any surgical technique.

    Recall: Z-1331-2013 · Reported May 22, 2013

    Enforcement

    Recall Number
    Z-1331-2013
    Event ID
    65078
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    DePuy Orthopaedics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 22, 2013
    Initiation Date
    May 8, 2013
    Classification Date
    May 16, 2013
    Termination Date
    January 14, 2014
    Address
    700 Orthopaedic Dr, Warsaw, IN, 46582-3994, United States

    Description

    DePuy LifeLiner Stick & Cut Resistant Gloves Rt, Lg Part No. 5200-68-000 The gloves are designed to resist sticks and cuts and are not cut or puncture proof. These gloves are not required by any surgical technique.

    Reason

    LifeLiner Stick and Cut Resistant Gloves are being recalled because cases and individual glove packages were mispackaged, with right handed, large sized glove packaging containing left handed, large sized gloves.

    Code Info

    Lot - D12178C

    Distribution

    Worldwide Distribution - US (nationwide) including the states of IL, OH, NC, SC, MN, NV, TN and WA., and the countries of UK, Netherlands and Canada.

    Quantity

    180 gloves (120 gloves distributed in the US)