BEUDAMED
    FDA Enforcement Class II Ongoing

    Multifire Endo Hernia 0 12mm Stapler with 4.0mm Disposable Loading Unit , Part No. 174027 - Product Usage: has application in endoscopic general surgery procedures for fixation of mesh in the repair of hernial defects and in other surgical specialties for approximation of tissue(s).

    Recall: Z-2255-2020 · Reported June 10, 2020

    Enforcement

    Recall Number
    Z-2255-2020
    Event ID
    85689
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Covidien Llc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 10, 2020
    Initiation Date
    May 12, 2020
    Classification Date
    June 3, 2020
    Address
    15 Hampshire St, N/A, Mansfield, MA, 02048-1113, United States

    Description

    Multifire Endo Hernia 0 12mm Stapler with 4.0mm Disposable Loading Unit , Part No. 174027 - Product Usage: has application in endoscopic general surgery procedures for fixation of mesh in the repair of hernial defects and in other surgical specialties for approximation of tissue(s).

    Reason

    The product is recalled due to a manufacturing assembly error that may cause the staples to fail to properly advance within the staple cartridge when the instrument handle is compressed.

    Code Info

    Lots P9J0368Y P9J0369Y P9J0517Y P9K1300Y

    Distribution

    Worldwide distribution.

    Quantity

    12,610 total