BEUDAMED
    FDA Enforcement Class II Terminated

    Knee Arthroscopy Pack AMS2610, AMS2610(A, AMS3236, PSS2188(A, and PSS2208(A convenience custom kits used for general surgery in hospital operating room

    Recall: Z-0211-2017 · Reported October 26, 2016

    Enforcement

    Recall Number
    Z-0211-2017
    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

    Knee Arthroscopy Pack AMS2610, AMS2610(A, AMS3236, PSS2188(A, and PSS2208(A 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: 63879 1/23/2014 58286 3/18/2014 58810 6/21/2014 62512 10/18/2014 63024 12/13/2014 65774 2/25/2015 68072 4/17/2015 68548 4/25/2015 70982 11/26/2015 73402 3/14/2016 74837 3/22/2016 75198 4/20/2016 67703 7/1/2016 78551 7/30/2016 78600 7/30/2016 68823 9/11/2016 68713 9/20/2016 71080 12/26/2016 72020 1/10/2017 73647 1/28/2017 73205 3/9/2017 73034 3/23/2017 77621 7/21/2017 79992 8/1/2017 77815 8/11/2017 80859 8/31/2017 77783 10/10/2017 75744 10/21/2017 79326 1/13/2018

    Distribution

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

    Quantity

    N/A