BEUDAMED
    FDA Recall Terminated

    Aortic Perfusion Cannula with plastic tip, 22 Fr. x 28 cm Edwards Lifesciences

    Recall: Z-1091-06 · Initiated April 18, 2006

    Recall

    Recall Number
    Z-1091-06
    Event Number
    35291
    Firm
    Edwards Lifesciences Research Medical, Inc.
    FEI Number
    1713910
    Product Code
    DWF
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 18, 2006
    Posted
    June 9, 2006
    Terminated
    June 11, 2008
    Address
    6864 Cottonwood St, Midvale, UT, 84047-1083

    Description

    Aortic Perfusion Cannula with plastic tip, 22 Fr. x 28 cm Edwards Lifesciences

    Reason

    Due to potential embrittlement of the plastic tip which may crack or separate during use.

    Action

    Consignees were notified by letter and visit beginning 04/18/2006.

    Distribution

    CA, CT, FL, IN, KS, MA, MI, TN, TX. No Military or government consignees. Foreign distribution to Australia, Chile, EU, India, Singapore, Taiwan

    Quantity

    190 units (Domestic), 800 units (Foreign).