BEUDAMED
    FDA Enforcement Class II Terminated

    Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 5cm UPN: M00536630

    Recall: Z-0550-2020 · Reported December 4, 2019

    Enforcement

    Recall Number
    Z-0550-2020
    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 5cm UPN: M00536630

    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: 21483840 21512594 21724125 21833851 22007180 22195528 22212528 22647190 22828072 23000367 23257632 23578453 23615959 23796006 24167478 24229865 24396823

    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

    542 units