BEUDAMED
    FDA Recall Terminated

    Implantable Chest Ports labeled: Titanium Single Lumen Port with PASV valve and 6.6F Silicone Catheter. Boston Scientific Cat. # PRTA66P M001PRTA66P0. Firm on label: Boston Scientific Natick, MA and Boston Scientific Corp., Glens Falls, NY.

    Recall: Z-0343-06 · Initiated October 28, 2005

    Recall

    Recall Number
    Z-0343-06
    Event Number
    33858
    Firm
    Boston Scientific Corporation
    FEI Number
    3001451463
    Product Code
    LJS
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 28, 2005
    Posted
    January 6, 2006
    Terminated
    February 15, 2007
    Address
    1 Boston Scientific Pl, Natick, MA, 01760-1536

    Description

    Implantable Chest Ports labeled: Titanium Single Lumen Port with PASV valve and 6.6F Silicone Catheter. Boston Scientific Cat. # PRTA66P M001PRTA66P0. Firm on label: Boston Scientific Natick, MA and Boston Scientific Corp., Glens Falls, NY.

    Reason

    Device kits contain B. Braun Locking Tearaway Introducer Systems labeled as 7Fr but may contain 8 Fr sheaths.

    Action

    Boston Scientific letter dated 10/28/2005 sent via Federal Express. Customers (hospitals) instructed to remove and return product.

    Distribution

    DOMESTIC: Nationwide distribution. FOREIGN: Spain, France, Italy, Great Britain, Sweden, Jordan

    Quantity

    50 units