BEUDAMED
    FDA Enforcement Class II Terminated

    Ortho Minor Pack, part number AMS3710(A

    Recall: Z-1354-2017 · Reported March 8, 2017

    Enforcement

    Recall Number
    Z-1354-2017
    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

    Ortho Minor Pack, part number AMS3710(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 100234, 9/8/2019 84944, 6/4/2018 85366, 7/23/2018 85662, 9/29/2018 86669, 9/15/2018 87127, 11/21/2018 89042, 12/12/2018 89735, 11/12/2018 95813, 1/28/2019 96010, 1/26/2019 97466, 5/28/2019 98514, 6/30/2019 99386, 6/10/2019

    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

    664 kits