BEUDAMED
    FDA Enforcement Class II Terminated

    Covidien Duet TRS 45 3.5 mm Universal Straight Single Use Loading Unit. Product Code: DUET4535. Single Use Loading Unit (SULU) tissue reinforcement stapler. The Endo GIA Universal Staplers with Duet TRS reloads have applications in abdominal, gynecologic and pediatric surgery for resection, transection and creation of anastomoses. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures and for transection and resection of pancreas.

    Recall: Z-2432-2012 · Reported October 3, 2012

    Enforcement

    Recall Number
    Z-2432-2012
    Event ID
    63015
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Covidien LP
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 3, 2012
    Initiation Date
    August 21, 2012
    Classification Date
    September 21, 2012
    Termination Date
    August 30, 2016
    Address
    60 Middletown Ave, N/A, North Haven, CT, 06473-3908, United States

    Description

    Covidien Duet TRS 45 3.5 mm Universal Straight Single Use Loading Unit. Product Code: DUET4535. Single Use Loading Unit (SULU) tissue reinforcement stapler. The Endo GIA Universal Staplers with Duet TRS reloads have applications in abdominal, gynecologic and pediatric surgery for resection, transection and creation of anastomoses. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures and for transection and resection of pancreas.

    Reason

    Duet TRS may have the potential to injure adjacent anatomical structures which may result in life threatening post-operative complications

    Code Info

    All lot numbers

    Distribution

    Worldwide Distribution.

    Quantity

    433,528 units