BEUDAMED
    FDA Recall Terminated

    Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 3cm UPN: M00536610

    Recall: Z-0548-2020 · Initiated October 21, 2019

    Recall

    Recall Number
    Z-0548-2020
    Event Number
    84150
    Firm
    Boston Scientific Corporation
    FEI Number
    3005099803
    Product Code
    FGE
    Status
    Terminated
    Root Cause
    Incorrect or no expiration date
    Initiated
    October 21, 2019
    Posted
    November 25, 2019
    Terminated
    December 20, 2023
    Address
    300 Boston Scientific Way, Marlborough, MA, 01752-1291

    Description

    Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 3cm UPN: M00536610

    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

    Action

    Boston Scientific issued Notifications to consignees via Federal Express Priority mail on October 21, 2019. The notification instructs the account to check their inventory remove any affected product from their inventory, and return it to Boston Scientific. The notification also requests the completion of a Reply Verification Tracking Form.

    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

    109 units