BEUDAMED
    FDA Enforcement Class II Terminated

    Peri GYN, Kit number PSS2193(A convenience custom kits used for general surgery in hospital operating room

    Recall: Z-0259-2017 · Reported October 26, 2016

    Enforcement

    Recall Number
    Z-0259-2017
    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

    Peri GYN, Kit number PSS2193(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: 58336 3/5/2014 61990 8/20/2014 61732 9/10/2014 63878 2/9/2015 65773 2/25/2015 64610 3/27/2015 68071 8/5/2015 69931 10/26/2015 71918 2/15/2016 73291 2/22/2016 74558 6/14/2016 77064 7/14/2016 78767 9/5/2016 78000 9/8/2016

    Distribution

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

    Quantity

    430 kits