BEUDAMED
    FDA Enforcement Class II Terminated

    Plastic Kit, Kit number CMP1084(B convenience custom kits used for general surgery in hospital operating room

    Recall: Z-0262-2017 · Reported October 26, 2016

    Enforcement

    Recall Number
    Z-0262-2017
    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

    Plastic Kit, Kit number CMP1084(B 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: 58302 3/26/2014 59046 6/9/2014 60228 6/15/2014 60559 6/20/2014 63222 8/14/2014 61004 9/13/2014 61491 9/21/2014 63003 12/11/2014 64005 2/14/2015 63768 2/22/2015 64592 3/18/2015 65494 5/30/2015 67289 6/11/2015 67602 8/14/2015 68438 8/22/2015 68275 8/25/2015 69589 10/22/2015 70504 10/24/2015 71258 12/7/2015 71749 12/19/2015 72506 2/15/2016 72750 2/22/2016 74081 2/24/2016 73436 2/28/2016 56986 5/24/2016 76902 6/20/2016 77188 9/9/2016 77986 9/18/2016 78514 9/19/2016 79246 9/26/2016 80549 10/27/2016

    Distribution

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

    Quantity

    1164 Kits