BEUDAMED
    FDA Enforcement Class II Terminated

    Lap Band Pack, Kit number AMS1785(A convenience custom kits used for general surgery in hospital operating room

    Recall: Z-0215-2017 · Reported October 26, 2016

    Enforcement

    Recall Number
    Z-0215-2017
    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

    Lap Band Pack, Kit number AMS1785(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: 58289 10/17/2014 60644 2/19/2015 65363 2/28/2015 61474 7/23/2015 65877 11/1/2015 64537 11/30/2015 66998 1/31/2016 68952 1/31/2016 67661 2/29/2016 71625 2/29/2016 70410 4/30/2016 71947 5/31/2016 72877 5/31/2016 57137 6/7/2016 77238 6/30/2016 78143 6/30/2016 73985 8/31/2016 74752 8/31/2016 74973 8/31/2016 76523 8/31/2016

    Distribution

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

    Quantity

    390 kits