BEUDAMED
    FDA Enforcement Class II Terminated

    Total Joint Pack, Kit number 006358-5 and 006358-6 convenience custom kits used for general surgery in hospital operating room

    Recall: Z-0276-2017 · Reported October 26, 2016

    Enforcement

    Recall Number
    Z-0276-2017
    Event ID
    71968
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Windstone Medical Packaging, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 26, 2016
    Initiation Date
    April 22, 2015
    Classification Date
    October 20, 2016
    Termination Date
    October 25, 2016
    Address
    1602 4th Ave N, N/A, Billings, MT, 59101-1521, United States

    Description

    Total Joint Pack, Kit number 006358-5 and 006358-6 convenience custom kits used for general surgery in hospital operating room

    Reason

    The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.

    Code Info

    Lot Number/ Expiration Date: 58057 5/6/2014 58493 5/30/2014 61598 7/28/2014 59008 8/21/2014 60647 8/31/2014 62544 1/16/2015 63813 2/28/2015 66309 4/13/2015 67352 11/1/2015 73747 3/1/2016 77176 6/17/2016 56393 7/3/2016 79087 8/31/2016

    Distribution

    Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.

    Quantity

    58 kits