BEUDAMED
    FDA Enforcement Class II Terminated

    Laparoscopic Pack, part number AMS2499 Laparoscopic Pack, part number AMS2499(A Laparoscopic Pack, part number AMS2499(B

    Recall: Z-1330-2017 · Reported March 8, 2017

    Enforcement

    Recall Number
    Z-1330-2017
    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

    Laparoscopic Pack, part number AMS2499 Laparoscopic Pack, part number AMS2499(A Laparoscopic Pack, part number AMS2499(B

    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 84903, 7/25/2018 85836, 8/22/2018 86720, 9/30/2018 86873, 8/16/2018 87104, 8/30/2018 88049, 10/29/2018 88170, 10/5/2018 88378, 11/15/2018 88379, 12/2/2018 89576, 11/15/2018 89577, 12/2/2018 89721, 12/17/2018 94931, 1/29/2019 94932, 1/5/2019 95274, 1/27/2019 95596, 1/13/2019 95983, 6/10/2019 96593, 5/1/2019 97448, 5/28/2019 97653, 6/17/2019 97654, 6/24/2019 97655, 6/21/2019

    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

    1056 kits