Recall of 2008T Hemodialysis Delivery System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Fresenius Medical Care Renal Therapies Group, LLC.

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
  • Event ID
  • Event Risk Class
    Class 2
  • Event Number
  • Event Initiated Date
  • Event Date Posted
  • Event Status
    Open, Classified
  • Event Country
  • Event Source
  • Event Source URL
  • 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
    While reviewing documentation for the next software release of the 2008t, an r&d; technician identified that setting the uf goal to '0' introduces a discrepancy between the uf rate displayed and the actual uf pump rate. the software anomaly is also applicable to the 2008t machines that contained the 2.63 bug fix per dcaf 17-088. 2008t upgrade kits that contained the 2.63 bug fix are also affected. additionally, sw version 2.64 (in design freeze) is also impacted by this anomaly.
  • Action
    Fresenius Medical Care sent an Urgent Medical Device Correction letter dated April 24, 2017 to affected customers. the letter identified the affected product, problem and actions to be taken. For questions contact Technical Services at 1-800-227-2572.


  • Model / Serial
    2008T machines: 190766 2008T Hemodialysis System w/Bibag 190895 2008T GEN 2 Bibag without CDX  190766 = 00840861100910 (+Serial Number) 190895 = 00840861100927 (+Serial Number)ux=&Su;
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    US Nationwide Distribution
  • Product Description
    2008T, Hemodialysis Delivery System || Product Indicated for acute and chronic dialysis therapy.
  • Manufacturer


  • Manufacturer Address
    Fresenius Medical Care Renal Therapies Group, LLC, 920 Winter St, Waltham MA 02451-1521
  • Manufacturer Parent Company (2017)
  • Source