BEUDAMED
    FDA Recall Terminated

    DUET TRS 60 4.8MM STRAIGHT SULU Product Code: DUET6048 Product Usage: The ENDO GIA UNIVERSAL Staplers with Duet TRS SULUs 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-0997-2012 · Initiated January 12, 2012

    Recall

    Recall Number
    Z-0997-2012
    Event Number
    60901
    FEI Number
    1219930
    Product Code
    GDW
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    January 12, 2012
    Posted
    February 13, 2012
    Terminated
    August 24, 2016
    Address
    LP 60 Middletown Ave, Covidien, North Haven, CT, 06473-3908

    Description

    DUET TRS 60 4.8MM STRAIGHT SULU Product Code: DUET6048 Product Usage: The ENDO GIA UNIVERSAL Staplers with Duet TRS SULUs 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

    Duet TRS Straight and Articulating Single Use (SULU)Loading Staplers used in thoracic surgery may result in serious injury or death

    Action

    Covidien issued an Urgent Medical Device Recall letter dated January 12, 2012 to all affected customers. The letter identified the affected products, problem, and actions to be taken. Customers were instructed to immediately discontinue use of the device in thoracic surgery, Immediately advise all surgeons/surgery personnel of this recall and return products intended for thoracic use to Covidien by contacting Customer Service at [email protected] or 1-800-722-8772, option 1, to obtain a Return Goods Authorization prior to returning the affected units. Customers were advised to complete the Recall product return form in its entirety and return it with the returned units. For questions contact your Covidien representative or Quality Assurance at 203-492-5232.

    Distribution

    Worldwide Distribution - USA (nationwide) and the countries of: ¿esk¿ republika, ASSAGAY, Australia, Austria, Belgium, Bosnia, Herzegovina, Bulgaria Cairo,Egypt, Canada, Canary Islands, China, Croatia, Cyprus, Czech Republic, Denmark, Egypt, England, Finland, France, Germany, Guadeloupe, Hong Kong, Hungary, Iceland, India, Iran, Ireland, Israel, Italy, Japan, Jordan, Kingdom of Bahrain, Korea, Republic of Kuwait, Latvia, Lebanon, Libya, Luxembourg, Nederland, Nelspruit, New Redruth, New Zealand, Norway, Nouvelle Caledonie, Philippines, Poland, Portugal, Qatar, Reunion, Russia, Romania, Rustenburg, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Turkey, Taiwan, Thailand, Tunisia, Uae, Uae - Dubai, Umhlanga Rocks, United Kingdom, Vietnam and Wales.

    Quantity

    9,687 units