BEUDAMED
    FDA Recall Open, Classified

    Sensica Urine Output System

    Recall: Z-1293-2022 · Initiated May 19, 2022

    Recall

    Recall Number
    Z-1293-2022
    Event Number
    90251
    Firm
    C.R. Bard Inc
    FEI Number
    1018233
    Product Code
    EXS
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    May 19, 2022
    Address
    8195 Industrial Blvd Ne, Covington, GA, 30014-1497

    Description

    Sensica Urine Output System

    Reason

    Complaints relating to urine output measurement accuracy.

    Action

    The firm issued a recall notification via email and Fed Ex on 05/19/2022. The letter instructs the consignee to immediately discontinue use of the system, quarantine and store to prevent usage, share the notice with users of the product, and return the response form.

    Distribution

    US Nationwide.

    Quantity

    457 units