BEUDAMED
    FDA Recall Terminated

    The Bard Intra-abdominal Pressure Monitoring Device is composed of a tubing set used for infusing fluid into the urinary bladder through the Foley catheter sampling port. It utilizes a clamping device to occlude the urinary drainage tubing to form a fluid column through which pressure is measured.

    Recall: Z-1219-2020 · Initiated January 13, 2020

    Recall

    Recall Number
    Z-1219-2020
    Event Number
    84744
    Firm
    C.R. Bard Inc
    FEI Number
    1018233
    Product Code
    PHU
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    January 13, 2020
    Terminated
    April 12, 2021
    Address
    8195 Industrial Blvd NE, Covington, GA, 30014-1497

    Description

    The Bard Intra-abdominal Pressure Monitoring Device is composed of a tubing set used for infusing fluid into the urinary bladder through the Foley catheter sampling port. It utilizes a clamping device to occlude the urinary drainage tubing to form a fluid column through which pressure is measured.

    Reason

    Leaks or disconnect near the sampling port of the Intra Abdominal Pressure Monitoring Device which could lead to the potential of inaccurate readings. The measurement should be confirmed with other means, such as a new IAP system of the same kind or by choosing other diagnostic means such as but not limited to alternative systems, such as open IAP measurement options or exchanging the tubing system, which does not require invasive maneuvers.

    Action

    Letters were sent 01/13/2020 to the user level instructing the return of two specific product lots of IAP001, Lots NGDQ2943 and NGDS0622.

    Distribution

    Distributed Nationwide including Washington DC and Guaynabo PR; Distributed OUS to Belgium and Japan.

    Quantity

    1,300 total