BEUDAMED
    FDA Enforcement Class II Terminated

    Virginia Custom Pack, Kit number RMS1744 convenience custom kits used for general surgery in hospital operating room

    Recall: Z-0284-2017 · Reported October 26, 2016

    Enforcement

    Recall Number
    Z-0284-2017
    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

    Virginia Custom Pack, Kit number RMS1744 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: 59798 9/26/2014 59796 7/5/2015 59797 7/5/2015 61329 7/5/2015 60411 8/5/2015 61222 9/1/2015 60758 9/9/2015 66544 11/5/2015 66261 11/7/2015 64654 11/8/2015 61679 11/9/2015 63209 11/13/2015 62471 11/17/2015 61678 11/27/2015 65932 11/30/2015 62470 12/9/2015 63208 12/18/2015 63927 1/5/2016 64653 1/7/2016 64307 1/18/2016 63926 1/20/2016 68195 7/5/2016 68638 7/7/2016 67670 7/16/2016 66545 7/23/2016 69868 9/15/2016 69907 9/17/2016 68874 9/25/2016 70705 10/25/2016 69039 10/27/2016 70945 12/5/2016 70704 1/4/2017 71513 1/27/2017 71688 3/6/2017 71840 3/6/2017 73729 4/17/2017 73177 4/20/2017 73393 4/21/2017 73731 5/16/2017 74648 5/30/2017 75024 7/3/2017 75160 7/11/2017 75975 7/21/2017 76242 8/3/2017 76441 8/18/2017 77269 8/22/2017 78308 9/26/2017 77268 10/8/2017 78593 11/4/2017 79038 11/20/2017 79881 1/7/2018 79039 2/28/2018

    Distribution

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

    Quantity

    5388 kits