BEUDAMED
    FDA Recall Terminated

    Wallstent Endoscopic Biliary Endoprosthesis 10mm x 60mm, UPN H965430500

    Recall: Z-0608-2007 · Initiated December 20, 2006

    Recall

    Recall Number
    Z-0608-2007
    Event Number
    37068
    Firm
    Boston Scientific Corporation One Boston
    FEI Number
    3001451463
    Product Code
    FGE
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 20, 2006
    Posted
    March 13, 2007
    Terminated
    December 12, 2007
    Address
    Scientific Place Natick, MA, 01760

    Description

    Wallstent Endoscopic Biliary Endoprosthesis 10mm x 60mm, UPN H965430500

    Reason

    Guidewire restriction during use (excessive adhesive in the guidewire lumen)

    Action

    On December 20, 2006, Boston Scientific notified all US consignees by letter sent via Fed Ex Priority mail. Customers are instructed to remove affected product from inventory and return it to Boston Scientific. The notification also requested the completion of a Reply Verification Tracking Form as a method of documenting the presence or absence of affected product in inventory. Boston Scientific International Regulatory Affairs was notified and is responsible the monitoring foreign recall.

    Distribution

    Worldwide distribution --- USA and countries of Austria, Belgium, France, Czech Republic, Germany, great Britain, Greece,Ireland, Italy, Luxemburg, Netherlands, Norway, Poland, Portugal, Spain, Switzerland, and Sweden.

    Quantity

    8,511 for Recalls Z-0604-0609-2007