BEUDAMED
    FDA Enforcement Class II Terminated

    Eye Plastic Tray, Kit number PSS1931(A convenience custom kits used for general surgery in hospital operating room

    Recall: Z-0186-2017 · Reported October 26, 2016

    Enforcement

    Recall Number
    Z-0186-2017
    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

    Eye Plastic Tray, Kit number PSS1931(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 56700 2/25/2014 57515 4/17/2014 62330 8/13/2014 61942 8/29/2014 59216 10/8/2014 63015 1/2/2015 62624 1/6/2015 68055 6/9/2015 66922 6/26/2015 68289 8/28/2015 68448 10/13/2015 72101 11/18/2015 72971 2/28/2016 75676 5/16/2016 76488 9/4/2016 78162 11/13/2016 79264 1/6/2017

    Distribution

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

    Quantity

    720 kits