BEUDAMED
    FDA Recall Terminated

    Millar Disposable Angiographic Catheter (Left Heart), manufactured for Millar Instruments, Inc 6001-A Gulf Freeway, Houston, Texas 77023

    Recall: Z-0401-2011 · Initiated October 14, 2010

    Recall

    Recall Number
    Z-0401-2011
    Event Number
    57015
    Firm
    Millar Instruments, Inc
    FEI Number
    1625382
    Product Code
    DQO
    Status
    Terminated
    Root Cause
    Packaging
    Initiated
    October 14, 2010
    Posted
    November 17, 2010
    Terminated
    February 15, 2011
    Address
    6001-A Gulf Fwy, Houston, TX, 77023

    Description

    Millar Disposable Angiographic Catheter (Left Heart), manufactured for Millar Instruments, Inc 6001-A Gulf Freeway, Houston, Texas 77023

    Reason

    The sterile packaging was found to be compromised when tested after shipping conditions. This may result in infection or transmission of disease. A test for transportation of sterile package was conducted and resulted in several samples failing.

    Action

    Millar issued a Recall Report letter on October 14, 2010 to consignees identifying the affected product, sterility issue, and actions to be taken. Customers are to return all unused catheters to Millar for replacement. Customers can contact Millar about this recall at 832-667-7131.

    Distribution

    Worldwide Distribution: USA, including the states of MA, OH, PA, and D.C., and the countries of Canada and Germany.

    Quantity

    12 Units