BEUDAMED
    FDA Recall Terminated

    DUET TRS 60 4.8mm Universal Articulating Single Use Loading Unit Surgical Stapler with Implantable Staples Reference Number: DUET6048A The ENDO GIA Universal Staplers with DUET TRS Loading Unit have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection, and creation of anastomosis. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures.

    Recall: Z-3171-2011 · Initiated August 15, 2011

    Recall

    Recall Number
    Z-3171-2011
    Event Number
    59798
    FEI Number
    1219930
    Product Code
    GDW
    Status
    Terminated
    Root Cause
    Storage
    Initiated
    August 15, 2011
    Posted
    September 8, 2011
    Terminated
    August 24, 2016
    Address
    LP 60 Middletown Ave, Covidien, North Haven, CT, 06473-3908

    Description

    DUET TRS 60 4.8mm Universal Articulating Single Use Loading Unit Surgical Stapler with Implantable Staples Reference Number: DUET6048A The ENDO GIA Universal Staplers with DUET TRS Loading Unit have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection, and creation of anastomosis. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures.

    Reason

    Sterility of the device is compromised due to a breach in the sterile packaging

    Action

    The firm, Covidien, sent an "URGENT MEDICAL DEVICE RECALL" letter dated August 15, 2011, to its customers via federal express. The letter describes the product, problem, and actions to be taken. The customers were instructed to immediately identify and quarantine all affected inventory (Note: Units from the affected lots may have been incorporated into Covidien BEST PRACTICE KITS. If you have purchased BEST PRACTICE KITS, please evaluate whether these kits contain units from the affected lots.); complete and return the DUET TRS Universal Loading Unit Recalled Product Return form via fax to (203) 822-6009; and return all inventory from the affected lots (note: All affected units must be returned) with the complete form to: Field Returns Department, located at 195 McDermott Road, North Haven, CT 06473. Questions or concerns, contact Covidien Representative or Covidien Quality Assurance at (203) 492-5232.

    Distribution

    Worldwide distribution: USA (nationwide) and countries of: Asia, Australia, Canada, Europe, Japan, Latin America, and Pacific.

    Quantity

    168427 units