Events

Recall of Device Recall Optiflux F250NRe Hemodialyzer

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
    57947
  • Event Risk Class
    Class 2
  • Event Number
    Z-1622-2011
  • Event Initiated Date
    2011-02-16
  • Event Date Posted
    2011-03-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-02-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97801
  • 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
    There is an increased risk of an internal blood leak.
  • Action
    FMCNA notified consignees on 2/16/11 by telephone and follow-up with an Urgent FMCNA Optiflux F250NRe Recall letter via Certified Mail, return Receipt requested. The firm states in the letter that there is an increased risk of an internal blood leak affecting a small percentage of the two lots of dialyzers. They are asking customers to examine their inventory, to discontinue use, and segregate the affected product in a secure place. Customers are to contact their FMCNA Customer Service Team at 1-800-323-5188 for instructions on how to return product. Used dialyzers should not be returned. If there are any questions, Customer Service should be contacted.

Device

Device Recall Optiflux F250NRe Hemodialyzer
  • Model / Serial
    Lot numbers:  10HU02012, Expiration Date: 06/30/2013; and  10LU02016, Expiration Date: 09/30/2013.
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA and Canada.
  • Product Description
    Fresenius Optiflux F250NRe Hemodialyzer, Single Use, Catalog Number: 0500325E, Advanced Fresenius Polysulfone. || Intended for use as an artificial kidney system to the treatment of patients with renal failure, fluid overload, or toxemic conditions by performing such therapies as hemodialysis, hemofiltration, hemoconcentration and hemodiafiltration.
  • 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