Events

Recall of Device Recall Fresenius Home Dialysis 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
    Recall
  • Event ID
    76037
  • Event Risk Class
    Class 2
  • Event Number
    Z-1028-2017
  • Event Initiated Date
    2016-12-21
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=152020
  • 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
    When the uf rate, goal or time is adjusted using the up and down arrow keys, and the change is cancelled by using the esc key, the cancelled uf rate is actually being executed rather than rate displayed on the machine.
  • Action
    Fresenius issued Customer Notification via Certified Mail on 12/21/2016. Users provided with problem and recommendation, when adjusting the UF Rate, UF Goal, or Tx Time, is to use the numeric data entry keys instead of the up or down arrow keys. Change the values by using data entry keys, then save by pressing CONFIRM. Fresenius will make arrangements to install software on the hemodialysis machine. Confirmation of the noticed by the consignee will be required via a Reply Form.

Device

Device Recall Fresenius Home Dialysis System

Manufacturer

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