Events

Recall of Dialog Hemodialysis machine: Dialog A HE/BIC

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by B Braun Medical Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    73744
  • Event Risk Class
    Class 1
  • Event Number
    Z-1535-2016
  • Event Initiated Date
    2016-04-01
  • Event Date Posted
    2016-05-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-07-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144895
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Dialyzer, high permeability with or without sealed dialysate system - Product Code KDI
  • Reason
    Potential leakage of conductivity sensors of the dialog dialysis machines.
  • Action
    B. Braun mailed an Urgent Medical Device Correction notice to affected customers informing them of the Dialog+Hemodialysis System due to the potential for Bicarbonate and End conductivity cells (3456102A and 3456103A respectively) to exhibit cracks. Notice provided customers with actions for Qualified Service Technicians, Clinical Personnel Administering Dialysis treatment and adverse event reporting. All Dialog+Hemodialysis machines will be inspected at the customer's site by the customer Biomed, who has been trained and qualified by B. Braun Avitum. The inspection of each machine will be performed in accordance to a Field Service Information (FSI). Customers with questions were instructed to contact the Technical Support Team at 800-621-0445 or the Customers Service Team at 800-848-2066. For questions regarding this recall call 610-997-4717.

Device

Dialog Hemodialysis machine: Dialog A HE/BIC
  • Model / Serial
    Item # 3456102A
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • 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
  • Product Description
    Dialog+ Hemodialysis machines: Conductivity Sensor (BIC) Item # 3456102A || 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.
  • Manufacturer
    B Braun Medical Inc

Manufacturer

B Braun Medical Inc
  • Manufacturer Address
    B Braun Medical Inc, 824 12th Ave, Bethlehem PA 18018-3524
  • Manufacturer Parent Company (2017)
    Ludwig G. Braun Gmbh U. Co. Kg
  • Source
    USFDA