BEUDAMED
    FDA Enforcement Class II Terminated

    Ortho Basic Pack, part number AMS6459 Product packaged in a convenient manner for use in a general clinical procedure

    Recall: Z-1795-2017 · Reported April 19, 2017

    Enforcement

    Recall Number
    Z-1795-2017
    Event ID
    76774
    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
    April 19, 2017
    Initiation Date
    March 16, 2017
    Classification Date
    April 11, 2017
    Termination Date
    June 6, 2017
    Address
    1602 4th Ave N, N/A, Billings, MT, 59101-1521, United States

    Description

    Ortho Basic Pack, part number AMS6459 Product packaged in a convenient manner for use in a general clinical procedure

    Reason

    AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential for the sterile packaging of the eye pad to be compromised.

    Code Info

    Lot number: 101180

    Distribution

    Nationwide Distribution including CA, CO, FL, GA, IA, KY, MA, MN, MO, ND, NJ, NV, OH, SD, TX, UT, WI, and WY.

    Quantity

    12 kits