BEUDAMED
    FDA Enforcement Class II Terminated

    Lap Band Pack, part number AMS1785(A

    Recall: Z-1324-2017 · Reported March 8, 2017

    Enforcement

    Recall Number
    Z-1324-2017
    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

    Lap Band Pack, part number AMS1785(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 85157, 2/28/2017 86861, 2/28/2017 87419, 4/30/2017 88367, 3/31/2017 89154, 7/31/2017 94568, 7/31/2017 94919, 11/30/2017 95972, 10/31/2017 96744, 11/30/2017 97772, 11/30/2017 98016, 11/30/2017 98495, 3/31/2018

    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

    252 kits