BEUDAMED
    FDA Enforcement Class II Terminated

    Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 7cm UPN: M00536650

    Recall: Z-0552-2020 · Reported December 4, 2019

    Enforcement

    Recall Number
    Z-0552-2020
    Event ID
    84150
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Boston Scientific Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 4, 2019
    Initiation Date
    October 21, 2019
    Classification Date
    November 25, 2019
    Termination Date
    December 20, 2023
    Address
    300 Boston Scientific Way, Marlborough, MA, 01752-1291, United States

    Description

    Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 7cm UPN: M00536650

    Reason

    Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 36-month shelf life rather than the approved 18-month shelf life

    Code Info

    Lot Numbers: 21187998 21285271 21337147 21483841 21512595 21662812 21724126 21833852 21922988 22036149 22136471 22307745 22359735 22613955 22700891 23035017 23295961 23492660 23541961 24006978 24271828 24383293 24411526

    Distribution

    Nationwide Foreign: Austria Australia Belgium Bulgaria Croatia Czech Rep Denmark Finland France Germany Great Britain Italy Japan Pakistan Poland Russian Fed. Slovakia South Africa Spain Sweden Switzerland Thailand Turkey

    Quantity

    940 units