BEUDAMED
    FDA Recall Terminated

    FlexTray"Procedure Delivery System ENDOPATH; FBW67XL, FD064, FDB15, TGL45XL, XBB02B, XBB58S, XBB59S, XLB01B, XLB50S, XPD51S. Utilized during general, gynecologic, urologic, and thoracic surgery for transection, resection, and/or creation of anastomoses.

    Recall: Z-2164-2008 · Initiated April 24, 2008

    Recall

    Recall Number
    Z-2164-2008
    Event Number
    48604
    Firm
    Ethicon Endo-Surgery Inc
    FEI Number
    1527736
    Product Code
    FZT
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 24, 2008
    Posted
    August 25, 2008
    Terminated
    April 3, 2012
    Address
    4545 Creek Rd, Cincinnati, OH, 45242-2803

    Description

    FlexTray"Procedure Delivery System ENDOPATH; FBW67XL, FD064, FDB15, TGL45XL, XBB02B, XBB58S, XBB59S, XLB01B, XLB50S, XPD51S. Utilized during general, gynecologic, urologic, and thoracic surgery for transection, resection, and/or creation of anastomoses.

    Reason

    The firm discovered a component production issue which may cause the cartridge to deploy an incomplete staple line.

    Action

    Firm issued an Urgent: Device Recall notification instructing the user to not use products from these lot numbers. Examine their inventory immediately to determine if they have affected product on hand and remove them from inventory. Complete the Business Reply Form and fax it back. To return affected product, copy the BRF, place in box with your product, and affix the pre-printed UPS shipping label.

    Distribution

    Worldwide Distribution --- including USA and countries of ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BELGIUM, BRAZIL, CAYMAN ISLANDS, CANADA, CHILE, CHINA, COLOMBIA, CZECH REPUBLIC, EGYPT, EL SALVADOR, FRANCE, GERMANY, GREECE, HONG KONG, HUNGARY, INDIA, ISRAEL, ITALY, JAPAN, KOREA, KUWAIT, LEBANON, MEXICO, PAKISTAN, POLAND, PORTUGAL, PUERTO RICO, RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SLOVENIA, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM & VENEZULA.

    Quantity

    863 pieces