BEUDAMED
    FDA Enforcement Class II Terminated

    Upper Extremity Pack, part number AMS4670 Upper Extremity Pack, part number AMS4670(A

    Recall: Z-1378-2017 · Reported March 8, 2017

    Enforcement

    Recall Number
    Z-1378-2017
    Event ID
    76280
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Windstone Medical Packaging, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    March 8, 2017
    Initiation Date
    January 11, 2017
    Classification Date
    February 28, 2017
    Termination Date
    May 3, 2017
    Address
    1602 4th Ave N, N/A, Billings, MT, 59101-1521, United States

    Description

    Upper Extremity Pack, part number AMS4670 Upper Extremity Pack, part number AMS4670(A

    Reason

    The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

    Code Info

    Lot number and expiration date 100052, 9/16/2018 84369, 6/20/2017 84721, 6/26/2017 84951, 6/21/2017 85377, 7/26/2017 86594, 10/8/2017 86595, 10/11/2017 87312, 10/24/2017 87990, 10/6/2017 88277, 10/26/2017 88668, 11/1/2017 89203, 12/16/2017 89605, 12/17/2017 94907, 12/28/2017 94968, 12/5/2017 95303, 2/27/2018 95476, 2/20/2018 96326, 2/1/2018 96619, 2/10/2018 96788, 2/1/2018 96950, 1/5/2018 97302, 3/20/2018 97596, 4/28/2018 97819, 3/15/2018 98048, 3/24/2018 98529, 5/30/2018 98710, 6/10/2018 98945, 5/24/2018 98946, 6/7/2018

    Distribution

    Distributed in AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NV, OH, PA, TX, UT, VA, and WA.

    Quantity

    1787 kits