BEUDAMED
    FDA Enforcement Class II Terminated

    Abdominoplasty Tray, there are two Kit part numbers: PSS1782 and PSS1782(A. convenience custom kits used for general surgery in hospital operating room

    Recall: Z-0140-2017 · Reported October 26, 2016

    Enforcement

    Recall Number
    Z-0140-2017
    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

    Abdominoplasty Tray, there are two Kit part numbers: PSS1782 and PSS1782(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 kit were recalled because gloves may contain splits or holes compromising sterility.

    Code Info

    Lot Numbers/Expiration Dates: 62789 11/7/2015 61201 11/8/2015 63413 11/9/2015 67096 11/9/2015 64598 1/29/2016 74803 6/26/2016 57510 6/27/2016 67607 8/21/2016 69801 9/15/2016 71002 10/6/2016 68446 10/9/2016 71403 12/24/2016 72095 1/14/2017 78759 11/5/2017 81077 2/13/2018

    Distribution

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

    Quantity

    192 kits