BEUDAMED
    FDA Recall Terminated

    Covidien Duet TRS Articulating 60- 3.5MM, Single Use Loading Unit Ref: DUET6035A The ENDO GIA Universal Staplers with DUET TR S Loading Units have applications in abdominal, gynecologic and pediatric surgery for resection, transection, and creation of anastomosis. They may be used for transaction and resection of liver substance, hepatic vasculature and biliary structures and for transection and resection of pancreas

    Recall: Z-1227-2012 · Initiated February 16, 2012

    Recall

    Recall Number
    Z-1227-2012
    Event Number
    61243
    FEI Number
    1219930
    Product Code
    GDW
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    February 16, 2012
    Posted
    March 19, 2012
    Terminated
    March 4, 2021
    Address
    LP 60 Middletown Ave, Covidien, North Haven, CT, 06473-3908

    Description

    Covidien Duet TRS Articulating 60- 3.5MM, Single Use Loading Unit Ref: DUET6035A The ENDO GIA Universal Staplers with DUET TR S Loading Units have applications in abdominal, gynecologic and pediatric surgery for resection, transection, and creation of anastomosis. They may be used for transaction and resection of liver substance, hepatic vasculature and biliary structures and for transection and resection of pancreas

    Reason

    Missing component results in the stapler not firing.

    Action

    The firm, Covidien, sent a "Medical Device Recall" letter dated February 16, 2012 to customers via federal express. The letter described the product, problem and actions to be taken. The customers were instructed to immediately discontinue use of Lot# N1H003LX of Duet TRS Articulating Loading Unit and segregate affected product; return inventory to Field Returns Department, 195 McDermott Road, North Haven, CT 06473 and contact customer service at [email protected] or (800) 722-8772, option #1 for RGA # prior to returning; and complete and return the Recall Product Return Form via fax to (203) 822-6009 (all affected units must be returned with completed form through the Distributor). If you have any questions or concerns, please do not hesitate to contact your Covidien representative or Quality Assurance at 203-492-5232, or Customer Service at 800-722-877 option 1 customer service.

    Distribution

    Worldwide distribution: USA (nationwide) and country of: Venezuela.

    Quantity

    1158 units