Events

Recall of 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
    66339
  • Event Risk Class
    Class 2
  • Event Number
    Z-0148-2014
  • Event Initiated Date
    2013-10-14
  • Event Date Posted
    2013-11-05
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122079
  • 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
    Fluid leaking may be observed inside the pump compartment of the liberty cycler and may result in dialysate becoming contaminated, potentially causing peritonitis.
  • Action
    Fresenius Medical Care contacted all affected consignees by telephone on 10/14/13 to inform them of the product safety alert. Follow-up Urgent Safety Alert letter was sent on 10/18/13 and 10/23/13 by Certified Mail, Return Receipt requested. The letter identified the affected product, problem and actions to be taken. Customers were instructed to report any events associated with this safety alert to Customer Service Team at 1-800-323-5188.

Device

Fresenius
  • Model / Serial
    All serial numbers
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    USA Nationwide Distribution
  • Product Description
    Fresenius Liberty¿ Cycler || Part Number: RTLR180111 || Product Usage: || The Liberty cycler is a portable device designed to perform acute and chronic peritoneal dialysis.
  • 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