BEUDAMED
    FDA Enforcement Class II Terminated

    Podiatry Kit PSS1040(A, PSS1040(B, and PSS1040(C convenience custom kits used for general surgery in hospital operating room

    Recall: Z-0264-2017 · Reported October 26, 2016

    Enforcement

    Recall Number
    Z-0264-2017
    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

    Podiatry Kit PSS1040(A, PSS1040(B, and PSS1040(C 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 Number/ Expiration Date: 63877 2/4/2015 65406 2/26/2015 65972 2/26/2015 64947 10/18/2015 61767 11/13/2015 64379 1/4/2016 63309 1/22/2016 57497 7/1/2016 67411 7/11/2016 58086 7/19/2016 77189 7/30/2016 68577 9/22/2016 69473 10/17/2016 72803 1/16/2017 72989 3/29/2017 73422 4/16/2017 76920 4/23/2017 73577 4/25/2017 74415 5/9/2017 74835 6/18/2017 76482 7/13/2017

    Distribution

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

    Quantity

    545 kits