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
    65332
  • Event Risk Class
    Class 2
  • Event Number
    Z-1674-2013
  • Event Initiated Date
    2013-06-03
  • Event Date Posted
    2013-07-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-06-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=118571
  • 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
    System, peritoneal, automatic delivery - Product Code FKX
  • Reason
    Cassette may leak during set up or during peritoneal dialysis treatment.
  • Action
    Fresenius Medical Care sent a Urgent Recall letter dated June 11, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to check their stock immediately and discontinue use and return product. Please contact your Fresenius Medical Care Customer Service Team at 1-800-323-5188 for instructions to return the product.

Device

Device Recall Fresenius
  • Model / Serial
    Lot 11PR08083
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    Fresenius Liberty Cycler Set Single Conn./Ext DL || Product Number: 050-87216 || Automated Peritoneal Dialysis System with integrated stay safe patient connector and extended drain line.
  • 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