BEUDAMED
    FDA Enforcement Class II Terminated

    Dr Bragg Vein Tray - RX, kit numbers 007912-5, 007912-6, 007912-7, 007912-8 convenience custom kits used for general surgery in hospital operating room

    Recall: Z-0173-2017 · Reported October 26, 2016

    Enforcement

    Recall Number
    Z-0173-2017
    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

    Dr Bragg Vein Tray - RX, kit numbers 007912-5, 007912-6, 007912-7, 007912-8 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: 61836 6/30/2013 58821 9/2/2013 60583 11/1/2013 62371 3/8/2014 65618 4/16/2014 64076 4/20/2014 67477 7/11/2014 69351 10/2/2014 69593 12/20/2014 72030 2/2/2016 73144 2/17/2016 72643 2/28/2016 74897 5/31/2016 77971 6/16/2016 76042 6/20/2016 56380 6/25/2016

    Distribution

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

    Quantity

    360 kits