BEUDAMED
    FDA Recall Terminated

    FLEXIMA Biliary Stent System, 7Fr-10cm, M00539220, Sterile EO, Boston Scientific, Spencer, IN. The Flexima Biliary Stent System is intended for delivery of the stent to the biliary tract for drainage of the bile ducts, for splinting of a bile duct during healing, or for providing bile duct patency in a stricture or past a stone.

    Recall: Z-1977-2010 · Initiated April 27, 2010

    Recall

    Recall Number
    Z-1977-2010
    Event Number
    55855
    Firm
    Boston Scientific Corporation
    FEI Number
    3001451463
    Product Code
    FGE
    Status
    Terminated
    Root Cause
    Packaging
    Initiated
    April 27, 2010
    Posted
    August 25, 2010
    Terminated
    March 23, 2011
    Address
    500 Commander Shea Blvd, Quincy, MA, 02171-1518

    Description

    FLEXIMA Biliary Stent System, 7Fr-10cm, M00539220, Sterile EO, Boston Scientific, Spencer, IN. The Flexima Biliary Stent System is intended for delivery of the stent to the biliary tract for drainage of the bile ducts, for splinting of a bile duct during healing, or for providing bile duct patency in a stricture or past a stone.

    Reason

    Flexima Biliary Stent System Devices were packaged with Tyvek tray lids that had incorrect adhesive, resulting in sterile barrier seal defects. The breach of the sterility barrier could lead to the device being non-sterile.

    Action

    Boston Scientific sent an "Urgent Medical Device Recall - Immediate Action Required" letter date April 27, 2010 to all consignees. The letter included instructions to immediately discontinue use and segregate the affected product for return, and complete and return by fax a Reply Verification Tracking Form. Customers with affected product were instructed to contact customer service at 866-868-4004 to obtain a Return Authorization (RGA) number, and package and ship the product to Boston Scientific.

    Distribution

    Worldwide Distribution: United States and Puerto Rico, and countries of Arab Emirates, Argentina, Austria, Belgium, Canada, China, Columbia, Croatia, El Salvador, Estonia, Finland, France, Great Britain, Germany, Greece, Hungary, Iran, Israel, Italy, Japan, Korea, Latvia, Lebanon, Malaysia, Mexico, the Netherlands, Norway, Poland, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, Ukraine, and Uruguay.

    Quantity

    1406