BEUDAMED
    FDA Enforcement Class II Terminated

    Basic Kit, Part numbers BP1110(C and CMP1109(A. convenience custom kits used for general surgery in hospital operating room

    Recall: Z-0146-2017 · Reported October 26, 2016

    Enforcement

    Recall Number
    Z-0146-2017
    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

    Basic Kit, Part numbers BP1110(C and CMP1109(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: 57495 7/3/2016 57946 6/29/2016 59013 8/22/2016 59014 3/28/2015 60496 9/1/2015 61879 11/6/2015 62950 11/28/2015 64294 1/7/2016 65396 11/3/2015 65981 11/1/2015 67215 7/16/2016 68373 9/4/2016 70215 9/15/2016 71010 10/17/2016 72059 3/21/2017 73446 3/7/2017 73960 4/5/2017 74662 5/9/2017 75137 5/5/2017 75760 7/13/2017 77133 7/17/2017 77727 8/16/2017 78449 9/15/2017 79367 1/25/2018 79939 1/17/2018

    Distribution

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

    Quantity

    53 kits