BEUDAMED
    FDA Enforcement Class II Terminated

    Conductivity Sensors utilized on Dialog and Dialog+ Hemodialysis Systems. Conductivity Sensor (BIC) - VERSION 2, Article Code Number 3456102A. These conductivity sensors may be used as spare parts for the following dialysis machines: 710200L (UDI 04046963686345), 710200S (UDI 04046964285608), 710200U (UDI 04046964285615), 710200K (UDI 04046963686338), 710500L (UDI Not applicable) and 710500K (UDI Not applicable).

    Recall: Z-0872-2022 · Reported April 20, 2022

    Enforcement

    Recall Number
    Z-0872-2022
    Event ID
    89784
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    B Braun Medical Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 20, 2022
    Initiation Date
    January 28, 2022
    Classification Date
    April 14, 2022
    Termination Date
    May 15, 2024
    Address
    824 12th Ave, N/A, Bethlehem, PA, 18018-3524, United States

    Description

    Conductivity Sensors utilized on Dialog and Dialog+ Hemodialysis Systems. Conductivity Sensor (BIC) - VERSION 2, Article Code Number 3456102A. These conductivity sensors may be used as spare parts for the following dialysis machines: 710200L (UDI 04046963686345), 710200S (UDI 04046964285608), 710200U (UDI 04046964285615), 710200K (UDI 04046963686338), 710500L (UDI Not applicable) and 710500K (UDI Not applicable).

    Reason

    Firm learned of the potential for cracks to form in the conductivity sensors during use, which may lead to a leak in the dialysate circuit. This could result in excessive ultrafiltration or insufficient ultrafiltration depending on whether the dialysis machine is equipped with a Dialysis Fluid filter.

    Code Info

    Lots 4/21 and 5/21

    Distribution

    US Nationwide distribution.

    Quantity

    80