BEUDAMED
    FDA Enforcement Class II Terminated

    General Pack I, Kit number CMP1811(B convenience custom kits used for general surgery in hospital operating room

    Recall: Z-0194-2017 · Reported October 26, 2016

    Enforcement

    Recall Number
    Z-0194-2017
    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

    General Pack I, Kit number CMP1811(B 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: 59313 4/12/2015 59483 7/22/2015 59876 9/13/2015 61092 9/13/2015 60552 10/29/2015 65936 11/2/2015 61362 11/7/2015 62976 11/8/2015 65432 11/8/2015 66398 11/10/2015 61093 11/15/2015 62301 11/18/2015 62676 12/14/2015 64312 1/6/2016 64793 1/12/2016 64183 1/14/2016 63524 1/17/2016 57212 6/16/2016 57213 7/5/2016 67910 7/15/2016 67594 7/27/2016 58074 8/7/2016 58649 8/30/2016 70167 9/15/2016 67911 9/18/2016 68879 10/9/2016 69319 10/31/2016

    Distribution

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

    Quantity

    1596 kits