BEUDAMED
    FDA Enforcement Class II Terminated

    AMS 4675 Angio Pack. For use in a general clinical procedure.

    Recall: Z-0377-2016 · Reported December 16, 2015

    Enforcement

    Recall Number
    Z-0377-2016
    Event ID
    72604
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Windstone Medical Packaging, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    December 16, 2015
    Initiation Date
    November 2, 2015
    Classification Date
    December 4, 2015
    Termination Date
    August 17, 2016
    Address
    1602 4th Ave N, N/A, Billings, MT, 59101-1521, United States

    Description

    AMS 4675 Angio Pack. For use in a general clinical procedure.

    Reason

    AMS 4675 Angio Pack is recalled because this kit containing U-SDN 2 Part Ultra Modified Seldinger Needle which is recalled by supplier.

    Code Info

    Lot 84371, expiration date: 2/28/2017

    Distribution

    Distributed in AL and VA.

    Quantity

    40 kits