BEUDAMED
    FDA Recall Terminated

    18F Tri-Funnel Replacement Gastrostomy Tube

    Recall: Z-0836-06 · Initiated April 6, 2006

    Recall

    Recall Number
    Z-0836-06
    Event Number
    35140
    Firm
    Bard Access Systems, Inc
    FEI Number
    3006260740
    Product Code
    KGC
    Status
    Terminated
    Root Cause
    Error in labeling
    Initiated
    April 6, 2006
    Posted
    May 3, 2006
    Terminated
    August 12, 2009
    Address
    5425 Amelia Earhart Dr, Salt Lake City, UT, 84116-3713

    Description

    18F Tri-Funnel Replacement Gastrostomy Tube

    Reason

    Packaging for some gastrostomy tubes was labeled with incorrect balloon inflation data. An underinflated balloon may cause misplacement, slippage or premature removal of the tube. If an underinflated balloon allows the tube to be placed, or slip into, the stomal tract and not the stomach, there is a risk of infusion of fluids into the peritoneum. This carries the risk of infection.

    Action

    Consignees were notified by letter on 04/06/2006.

    Distribution

    Nationwide, including 4 VA facilities. No military consignees. Foreign distribution to Canada, Australia

    Quantity

    114 units