BEUDAMED
    FDA Enforcement Class II 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 · Reported February 19, 2020

    Enforcement

    Recall Number
    Z-1219-2020
    Event ID
    84744
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    C.R. Bard Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 19, 2020
    Initiation Date
    January 13, 2020
    Classification Date
    February 13, 2020
    Termination Date
    April 12, 2021
    Address
    8195 Industrial Blvd NE, Covington, GA, 30014-1497, United States

    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.

    Code Info

    Product Code IAP001 lot numbers NGDQ2943 and NGDS0622.

    Distribution

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

    Quantity

    1,300 total