BEUDAMED
    FDA Enforcement Class II Terminated

    Dr. Landi EVLT Pack, Kit numbers AMS1483(A, AMS1483(B, and AMS1483(C convenience custom kits used for general surgery in hospital operating room

    Recall: Z-0178-2017 · Reported October 26, 2016

    Enforcement

    Recall Number
    Z-0178-2017
    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. Landi EVLT Pack, Kit numbers AMS1483(A, AMS1483(B, and AMS1483(C 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: 59444 7/10/2014 60056 8/8/2014 60425 8/20/2014 60967 11/3/2014 59000 1/13/2015 63464 2/9/2015 64533 2/25/2015 61267 2/27/2015 63798 3/30/2015 65629 7/30/2015 66813 10/21/2015 69765 11/2/2015 69528 11/18/2015 67138 11/19/2015 67399 1/2/2016 67989 2/6/2016 70374 3/17/2016 69766 3/30/2016 71447 4/18/2016 72241 5/15/2016 57208 7/24/2016 75250 8/7/2016 58621 8/10/2016 73977 8/11/2016 73190 8/12/2016 73277 8/23/2016 74340 8/26/2016 78679 10/24/2016 79046 10/25/2016 75603 1/26/2017 76940 2/11/2017 76159 2/14/2017 78015 6/16/2017 76568 6/26/2017 79824 7/25/2017 81121 8/13/2017 68922

    Distribution

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

    Quantity

    2048 kits