BEUDAMED
    FDA Enforcement Class II Terminated

    BARD UROS AUTOMATED URINE OUPTUT AND TEMPERATURE MONITOR, MODEL BK10001M The Uros(TM) Automated Urine Output and Temperature Monitor is indicated to monitor urine output and core bladder temperature.

    Recall: Z-0488-2018 · Reported February 7, 2018

    Enforcement

    Recall Number
    Z-0488-2018
    Event ID
    78231
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    C.R. Bard, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 7, 2018
    Initiation Date
    September 29, 2017
    Classification Date
    January 29, 2018
    Termination Date
    July 7, 2021
    Address
    8195 Industrial Blvd NE, Covington, GA, 30014-1497, United States

    Description

    BARD UROS AUTOMATED URINE OUPTUT AND TEMPERATURE MONITOR, MODEL BK10001M The Uros(TM) Automated Urine Output and Temperature Monitor is indicated to monitor urine output and core bladder temperature.

    Reason

    The possibility exists that use of the Uros Automated Urine Output and Temperature Monitor may lead to the loss of urine output measurement data and/or urine output measurement inaccuracies resulting in an impact on clinical treatment decisions.

    Code Info

    Catalog/PC #BK10001M

    Distribution

    US Distribution to the state of: FL

    Quantity

    2 units