BEUDAMED
    FDA Recall Terminated

    Silicone Central Venous Catheter with PASV Valve and Polyester Cuff - 6.6F. Boston Scientific Cat. #CVC661IK M001CVC661IK0. Firm on label: Boston Scientific Corporation, NAMIC Technology Center, Glens Falls, NY 12801.

    Recall: Z-0341-06 · Initiated October 28, 2005

    Recall

    Recall Number
    Z-0341-06
    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

    Silicone Central Venous Catheter with PASV Valve and Polyester Cuff - 6.6F. Boston Scientific Cat. #CVC661IK M001CVC661IK0. Firm on label: Boston Scientific Corporation, NAMIC Technology Center, Glens Falls, NY 12801.

    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

    434 units