BEUDAMED
    FDA Enforcement Class II Terminated

    Lower Extremity Pack, Kit number AMS1375(A, AMS2540, AMS2540(A, and AMS4669. convenience custom kits used for general surgery in hospital operating room

    Recall: Z-0228-2017 · Reported October 26, 2016

    Enforcement

    Recall Number
    Z-0228-2017
    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

    Lower Extremity Pack, Kit number AMS1375(A, AMS2540, AMS2540(A, and AMS4669. 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 numbers/Expiration dates: 62895 3/16/2014 61290 3/30/2014 57472 4/2/2014 59889 8/8/2014 61313 8/27/2014 62201 10/18/2014 63202 12/12/2014 64163 12/17/2014 65489 3/8/2015 68367 4/13/2015 66793 4/30/2015 69272 9/14/2015 70920 9/30/2015 71438 11/4/2015 66044 11/8/2015 64134 11/10/2015 65690 11/17/2015 71985 11/30/2015 65282 12/1/2015 68490 12/21/2015 69186 12/21/2015 71052 12/25/2015 67699 12/27/2015 67960 12/30/2015 72484 5/28/2016 69442 9/21/2016 80467 10/31/2016

    Distribution

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

    Quantity

    582 kits