BEUDAMED
    FDA Enforcement Class II Terminated

    Major Ortho Pack, kit number 002647-12 and 002647-13 convenience custom kits used for general surgery in hospital operating room

    Recall: Z-0235-2017 · Reported October 26, 2016

    Enforcement

    Recall Number
    Z-0235-2017
    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

    Major Ortho Pack, kit number 002647-12 and 002647-13 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: 59180 8/13/2013 58144 11/7/2013 63191 12/3/2013 62098 12/6/2013 61064 12/13/2013 61592 12/16/2013 63809 12/17/2013 62398 12/19/2013 60127 12/20/2013 59454 1/25/2014 66802 1/31/2014 67030 1/31/2014 59839 2/16/2014 61296 2/21/2014 65291 2/28/2014 68567 9/5/2014 62930 9/20/2014 67877 9/21/2014 64458 9/30/2014 71056 10/11/2015 68946 10/26/2015 69206 5/10/2016 69631 5/23/2016 70482 5/29/2016 71057 6/4/2016 57292 6/11/2016 57780 6/23/2016

    Distribution

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

    Quantity

    1200 kits