Events

Recall of Fresenius Medical

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

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
    30007
  • Event Risk Class
    Class 2
  • Event Number
    Z-0017-05
  • Event Initiated Date
    2004-09-20
  • Event Date Posted
    2004-10-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-06-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=34996
  • 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
    Set, Administration, For Peritoneal Dialysis, Disposable - Product Code KDJ
  • Reason
    Peritoneal dialysis transfer set may have occluded pathway.
  • Action
    Fresenius Medical is conducting telephone contact to the dialysis clinics starting 9/20/04 and follow-up with a notice to be mailed o/a 9/27/04.Clinics are requested to examine inventory for lot numbers and return unused product to Fresenius.

Device

Fresenius Medical
  • Model / Serial
    Lot Numbers: 3LR240, 3NR190, 3SR074, 4AR119, 4BR187, 4CR290
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Canada: Fresenius Medical Care Canada 258 East Pearce Street, Richmond Hill, ON
  • Product Description
    Fresenius Peritoneal Dialysis Premier Luer Lock Transfer Set 8'', Sterile || with Female Safe Lock Connector Luer Lock and Slide Clamp || Catalog Number: 050-30034
  • Manufacturer
    Fresenius Medical Care North America

Manufacturer

Fresenius Medical Care North America
  • Manufacturer Address
    Fresenius Medical Care North America, 95 Hayden Ave, Lexington MA 02421-7942
  • Source
    USFDA