Events

Recall of Fresenius Medical CombiSet True Flow"

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
    59664
  • Event Risk Class
    Class 2
  • Event Number
    Z-3269-2011
  • Event Initiated Date
    2011-08-11
  • Event Date Posted
    2011-09-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-08-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=103240
  • 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
    Autonomous Extracorporeal Blood Leak Detector/Alarm - Product Code ODX
  • Reason
    Blood lines coiling tabs #1 and #5 on the arterial line are not in the correct positions.
  • Action
    Fresenius Medical Care sent out an "Urgent" recall notice dated August 11, 2011 to all affected customers . The letter included description of the product name, problem and asked them to examine their stock immediately and quarantine bloodlines from the recalled lots. Customers were asked to return the product to Fresenius. For information on this recall call the Fresenius Customer Service Team at 1-800-323-5188.

Device

Fresenius Medical CombiSet True Flow"
  • Model / Serial
    Product Code: 03-2962-3  Lot Numbers: 11ER01800 11ER01801 11ER01802 11ER01804  Exp. Date 05-2014
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution.
  • Product Description
    CombiSet¿ True Flow" 2008K@home Bloodlines || Fresenius Medical Care. || Used for transferring blood during the hemodialysis treatment from the patient to the dialyzer (artificial kidney), removing extra water and waste products and then returning the filtered blood back to the patient
  • 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