BEUDAMED
    FDA Recall Terminated

    Huber Plus Non-Coring Needle Safety Infusion Set, 19g, 1 inch, Needless Y-site, REF 011901NY, Sterile EO, Assembled In Mexico, Bard Access Systems, Inc., SLC, UT 84116. Safety IV administration set used to access surgically implanted vascular ports.

    Recall: Z-0861-2010 · Initiated January 14, 2010

    Recall

    Recall Number
    Z-0861-2010
    Event Number
    53341
    Firm
    Bard Access Systems
    FEI Number
    3006260740
    Product Code
    FPA
    Status
    Terminated
    Root Cause
    Component change control
    Initiated
    January 14, 2010
    Posted
    February 26, 2010
    Terminated
    May 14, 2010
    Address
    605 North 5600, West Salt Lake City, UT, 84116-3738

    Description

    Huber Plus Non-Coring Needle Safety Infusion Set, 19g, 1 inch, Needless Y-site, REF 011901NY, Sterile EO, Assembled In Mexico, Bard Access Systems, Inc., SLC, UT 84116. Safety IV administration set used to access surgically implanted vascular ports.

    Reason

    After activation of the safety mechanism, the tip of the needle protrudes from the safety sheath creating the potential for needlestick injury.

    Action

    Bard Access Systems, Inc. issued and "Urgent: Huber Plus Non-Coring Needle Safety Infusion Set Recall" notification beginning January 2010. Users were instructed to quarantine all affected product and to notify any of their customers that had received the product. Quarantined product is to be returned to the firm. For further information, contact Bard Access Systems, Inc. at 1-800-290-1689.

    Distribution

    Worldwide Distribution -- United States (VA, KY, MA, NJ and TN) and Belgium.

    Quantity

    4,975 units