BEUDAMED
    FDA Enforcement Class II Terminated

    Breast Pack, Kit part number AMS3238, AMS3238(A, AMS3691, AMS4419, PSS1541, PSS1784, PSS1784(A, PSS1784(B, PSS2272, and PSS2272(A. convenience custom kits used for general surgery in hospital operating room

    Recall: Z-0156-2017 · Reported October 26, 2016

    Enforcement

    Recall Number
    Z-0156-2017
    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

    Breast Pack, Kit part number AMS3238, AMS3238(A, AMS3691, AMS4419, PSS1541, PSS1784, PSS1784(A, PSS1784(B, PSS2272, and PSS2272(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: 59572 3/1/2015 58932 4/24/2015 57078 7/8/2015 57694 7/14/2015 60620 8/4/2015 61768 11/4/2015 67414 11/16/2015 65034 1/17/2016 75189 4/16/2016 76805 4/17/2016 57372 6/19/2016 57636 6/20/2016 66625 7/29/2016 67295 9/27/2016 71082 9/28/2016 71404 12/21/2016 72826 1/16/2017 72162 1/27/2017 75661 6/18/2017 76889 7/16/2017 77066 7/19/2017 81026 1/13/2018 79638 1/9/2019

    Distribution

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

    Quantity

    505 kits