BEUDAMED
    FDA Recall Terminated

    Bard PowerLine 6 Fr. Dual-Lumen Polyurethane Catheter with SureCuff Ingrowth Cuff, REF 0700610, Sterile, Contents...1 Each - PTFE Introducer and Dilator, 6.5 FR. x 10 cm..., Assembled in Mexico. Product Usage: Designed for short or long term access to the central venous system. They are designed for the administration of I.V. fluids, blood products, drugs, parenteral nutrition solutions, as well as blood withdrawal and power injection of contrast media.

    Recall: Z-2783-2011 · Initiated June 20, 2011

    Recall

    Recall Number
    Z-2783-2011
    Event Number
    59115
    Firm
    Bard Access Systems
    FEI Number
    3006260740
    Product Code
    LJS
    Status
    Terminated
    Root Cause
    Labeling design
    Initiated
    June 20, 2011
    Posted
    July 11, 2011
    Terminated
    March 1, 2012
    Address
    605 North 5600, West Salt Lake City, UT, 84116-3738

    Description

    Bard PowerLine 6 Fr. Dual-Lumen Polyurethane Catheter with SureCuff Ingrowth Cuff, REF 0700610, Sterile, Contents...1 Each - PTFE Introducer and Dilator, 6.5 FR. x 10 cm..., Assembled in Mexico. Product Usage: Designed for short or long term access to the central venous system. They are designed for the administration of I.V. fluids, blood products, drugs, parenteral nutrition solutions, as well as blood withdrawal and power injection of contrast media.

    Reason

    Kit label indicates the wrong dimension for an enclosed introducer.

    Action

    Bard Access Systems, Inc. notified customers by letter dated June 16, 2011. The letter notified customers of the mislabeling issue and offered a replacement product if desired. For additional information contact Bard Access Systems at 1-800-443-3393.

    Distribution

    Worldwide distribution - USA (nationwide) including the states of: HI, KY, TX, VT and the country of Canada.

    Quantity

    6,485 units