BEUDAMED
    FDA Recall Terminated

    BardPort Titanium Implanted Port. Bard Access Systems. Assembled in Mexico. A totally implantable vascular access device designed to provide long term repeated access to the vascular system

    Recall: Z-3173-2011 · Initiated August 30, 2011

    Recall

    Recall Number
    Z-3173-2011
    Event Number
    59830
    Firm
    Bard Access Systems
    FEI Number
    3006260740
    Status
    Terminated
    Root Cause
    Labeling Change Control
    Initiated
    August 30, 2011
    Posted
    September 8, 2011
    Terminated
    March 30, 2012
    Address
    605 North 5600, West Salt Lake City, UT, 84116-3738

    Description

    BardPort Titanium Implanted Port. Bard Access Systems. Assembled in Mexico. A totally implantable vascular access device designed to provide long term repeated access to the vascular system

    Reason

    Implanted port has discrepant product information on package labeling.

    Action

    Bard Access System, Inc. sent a "Label Discrepancy Notification dated August 30, 2011 to all affected customers. The letter included affected product and informed them of the labeling discrepancy. Customers could either use the device or return it to Bard for replacement. For information on this recall call (801) 595-5568.

    Distribution

    Worldwide Distribution: Nationwide Distribution including the states of; AL, AR, AZ, CA, CT, DC, FL, GA, HI, IL, KY, LA, MA, MD, MI, MO, NJ, NV, NY, OK, PA, RI, SC, TN, TX, UT, VA, WI, and WV; and the countries of Canada and Belgium.

    Quantity

    1375 units