BEUDAMED
    FDA Enforcement Class II Terminated

    Dr Mullins Kit, kit number PSS1861(A convenience custom kits used for general surgery in hospital operating room

    Recall: Z-0174-2017 · Reported October 26, 2016

    Enforcement

    Recall Number
    Z-0174-2017
    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

    Dr Mullins Kit, kit number PSS1861(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: 65805 2/24/2015 59138 8/31/2015 61015 9/17/2015 65118 10/20/2015 65413 11/3/2015 66234 11/8/2015 66921 11/29/2015 57959 8/15/2016 69802 9/27/2016 68607 10/5/2016 71901 10/19/2016 71111 12/26/2016 72510 3/14/2017 76252 4/14/2017 76892 4/23/2017 74517 5/15/2017 73799 5/24/2017 75239 7/15/2017 77363 8/25/2017

    Distribution

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

    Quantity

    648 kits