BEUDAMED
    FDA Enforcement Class II Terminated

    Peri Kit, Kit number PSS1037 convenience custom kits used for general surgery in hospital operating room

    Recall: Z-0260-2017 · Reported October 26, 2016

    Enforcement

    Recall Number
    Z-0260-2017
    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 Kit, Kit number PSS1037 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: 57953 7/20/2016 58914 9/12/2015 61492 11/7/2015 62258 11/20/2015 63415 1/22/2016 63988 11/22/2015

    Distribution

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

    Quantity

    115 kits