BEUDAMED
    FDA Enforcement Class I Terminated

    Dialog+ Hemodialysis machines: Conductivity Sensor (BIC) Item 3456103A The Dialog+ can be used for implementing and monitoring hemodialysis treatments for patients with acute or chronic kidney failure. The system can be used in hospital, health center and outpatient dialysis center settings when prescribed by a Physician. The following types of renal replacement therapy can be carried out with the system: Hemodialysis (HD) with or without phases of pure ultrafiltration, High flux hemodialysis and low flux hemodialysis.

    Recall: Z-1536-2016 · Reported May 11, 2016

    Enforcement

    Recall Number
    Z-1536-2016
    Event ID
    73744
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    B Braun Medical Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 11, 2016
    Initiation Date
    April 1, 2016
    Classification Date
    May 3, 2016
    Termination Date
    July 11, 2017
    Address
    824 12th Ave, Bethlehem, PA, 18018-3524, United States

    Description

    Dialog+ Hemodialysis machines: Conductivity Sensor (BIC) Item 3456103A The Dialog+ can be used for implementing and monitoring hemodialysis treatments for patients with acute or chronic kidney failure. The system can be used in hospital, health center and outpatient dialysis center settings when prescribed by a Physician. The following types of renal replacement therapy can be carried out with the system: Hemodialysis (HD) with or without phases of pure ultrafiltration, High flux hemodialysis and low flux hemodialysis.

    Reason

    Potential leakage of conductivity sensors of the Dialog Dialysis machines.

    Code Info

    Item # 3456103A

    Distribution

    Nationwide Distribution to ND, OH, CA, VA, FL, LA, SC, IL, UT, AZ, KY, IA, WI, OK, TN, SD, AL, NJ, TX, NM, NY, KS, WA, MO, CO, PA, CT, DE, GA, MD, VA, Puerto Rico, and St. Thomas USVI

    Quantity

    147