BEUDAMED
    FDA Enforcement Class II Terminated

    Minor Pack AMS1374(A, CMP1560, PSS3517, PSS3517(A, PSS3518, PSS3518(A, PSS3541, and PSS3541(A. convenience custom kits used for general surgery in hospital operating room

    Recall: Z-0242-2017 · Reported October 26, 2016

    Enforcement

    Recall Number
    Z-0242-2017
    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

    Minor Pack AMS1374(A, CMP1560, PSS3517, PSS3517(A, PSS3518, PSS3518(A, PSS3541, and PSS3541(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: 59360 4/4/2015 60180 7/22/2015 60972 8/20/2015 60716 9/20/2015 61627 10/15/2015 65729 11/15/2015 65371 11/18/2015 62925 11/26/2015 64759 12/26/2015 63807 1/14/2016 64511 1/16/2016 65907 7/11/2016 57777 7/16/2016 67561 8/26/2016 69460 9/11/2016 69554 11/9/2016 72302 1/5/2017 71984 1/27/2017 73801 4/2/2017 74579 4/23/2017 78211 4/26/2017 74831 5/23/2017 74685 5/24/2017 74462 5/25/2017 74578 5/26/2017 75514 7/2/2017 77373 7/19/2017 78511 8/6/2017 75602 9/19/2017 79095 11/4/2017 79588 11/20/2017 79682 1/17/2018 79251 1/26/2018 81260 2/13/2018 80649 2/27/2018

    Distribution

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

    Quantity

    1025 kits