BEUDAMED
    FDA Recall Terminated

    Boston Scientific PCNL (Percutaneous Tract) Kit with Nephromax Balloon; Part Number: M0064501110

    Recall: Z-0889-2007 · Initiated April 11, 2007

    Recall

    Recall Number
    Z-0889-2007
    Event Number
    37886
    Firm
    Boston Scientific Corporation One Boston
    FEI Number
    3001451463
    Product Code
    LJE
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 11, 2007
    Posted
    June 5, 2007
    Terminated
    December 12, 2007
    Address
    Scientific Place Natick, MA, 01760

    Description

    Boston Scientific PCNL (Percutaneous Tract) Kit with Nephromax Balloon; Part Number: M0064501110

    Reason

    Mislabeled: Outer box unit has correct part number but product is incorrectly identiified as a Percutaneous Tract Kit with Nephromax Balloon. The box actually contains a Percutaneous Tract Kit with Amplatz Dilator and Sheath Kit

    Action

    Boston Scientific notified customers on 4/11/07 by letter via Federal Express mail. Users are requested to return product in inventory.

    Distribution

    Worldwide Distribution; USA including states of OH, MS, NM, MD, and TX and Foreign country of Trinidad

    Quantity

    15 kits