Events

Recall of Device Recall Fresenius

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Fresenius Medical Care Holdings, 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
    59483
  • Event Risk Class
    Class 2
  • Event Number
    Z-3083-2011
  • Event Initiated Date
    2011-05-04
  • Event Date Posted
    2011-08-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-08-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=102875
  • 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
    Hemodialysis system for home use - Product Code ONW
  • Reason
    Upgrade software to implement new on screen graphics and instructions, the addition of a bracket on the side of the machine to temporarily hold the bloodlines during set up in order to conform to approved 510(k).
  • Action
    Fresenius Medical NA issued a formal field correction notification dated May 4 ,2011, sent by certified mail with return receipt requested. The letter identified the product the problem and the action needed to be taken by the customer. The customer was notified of the retrofit that would be done to their machines. The patients' facilities were made aware of the changes that would be made to each of their patient's 2008K@home machines on May 4, 2011. On May 13, 2011, all facilities with active 2008K@home machines were sent a notification letter of the retrofit. Please return the receipt for confirmation that you have received this notice. Please call (781) 699-2053, to schedule a certified technician to conduct the machine retrofit.

Device

Device Recall Fresenius
  • Model / Serial
    All serial numbers
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution. Canada - FMCNA is not conducting the recall to Canada, as Health Canada did not require the same modifications to the machines
  • Product Description
    Fresenius 2008K@home || The Fresenius 2008K@home is indicated for acute and chronic dialysis therapy in an acute or chronic facility. The 2008K@home is also indicated for hemodialysis in the home and must be observed by a trained and qualified person as prescribed by their physician.
  • Manufacturer
    Fresenius Medical Care Holdings, Inc.

Manufacturer

Fresenius Medical Care Holdings, Inc.
  • Manufacturer Address
    Fresenius Medical Care Holdings, Inc., 920 Winter St, Waltham MA 02451-1521
  • Manufacturer Parent Company (2017)
    Fresenius SE & Co KGaA
  • Source
    USFDA