BEUDAMED
    FDA Recall Terminated

    Boston Scientific Impulse Flextrusion Shaft 5F FR4 16391-02 H74916391022, (5-Pack Carton Label), Angiographic Catheters. Made in Mexico Parque Industrial La Mesa Edificio G1, Suites B, H Tijuana, Baja California 22650 MEX Boston Scientific Impulse Flextrusion Shaft 5F FR4 16391-02 H74916391021, (Single Pack Carton/Pouch Label), Angiographic Catheters. Made in Mexico Parque Industrial La Mesa Edificio G1, Suites B, H Tijuana, Baja California 22650 MEX

    Recall: Z-1159-2007 · Initiated June 4, 2007

    Recall

    Recall Number
    Z-1159-2007
    Event Number
    38112
    Firm
    Boston Scientific Corporation One Boston
    FEI Number
    3001451463
    Product Code
    DQO
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    June 4, 2007
    Posted
    August 9, 2007
    Terminated
    December 19, 2007
    Address
    Scientific Place Natick, MA, 01760

    Description

    Boston Scientific Impulse Flextrusion Shaft 5F FR4 16391-02 H74916391022, (5-Pack Carton Label), Angiographic Catheters. Made in Mexico Parque Industrial La Mesa Edificio G1, Suites B, H Tijuana, Baja California 22650 MEX Boston Scientific Impulse Flextrusion Shaft 5F FR4 16391-02 H74916391021, (Single Pack Carton/Pouch Label), Angiographic Catheters. Made in Mexico Parque Industrial La Mesa Edificio G1, Suites B, H Tijuana, Baja California 22650 MEX

    Reason

    Labels on the carton from two batches/lots of Impulse Angiographic Catheters may indicate a different curve style than the device that is actually in the carton.

    Action

    Sales Force were contacted of the product and problem via voice mail and a memo dated June 4, 2007. Customers were contacted via a letter on June 4, 2007.

    Distribution

    Worldwide, including USA, Austria, Australia, Belgium, Chile, Germany, Spain, Finland, France, Great Britain, Greece, Ireland, Panama, Poland, Sweden, Thailand, and South Africa.

    Quantity

    235