Events

Recall of Device Recall Fresenius Medical Care

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
    35184
  • Event Risk Class
    Class 2
  • Event Number
    Z-0834-06
  • Event Initiated Date
    2006-03-22
  • Event Date Posted
    2006-05-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-07-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=45473
  • 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
    Stay safe trigger body may not connect to the extension set and result in associated peritonitis.
  • Action
    Fresenius Medical notified customers by telephone on 3/24/06 for initial lots recalled and followed by letter dated 3/30/06 to include all lots numbers recalled.

Device

Device Recall Fresenius Medical Care
  • Model / Serial
    Lot Numbers: 5SR119; 52R124; 5SR125; 5SR149; 5SR150; 5SR173; 6AR014; 6AR015; 6AR032; 6AR044; 6AR045; 6AR055; 6AR069; 6AR085; 06AR086; 6AR267; 6AR280;6AR298; 6BR013;6BR031; 6BR040; 6BR043; 6BR064; 6BR075; 6BR091; 6BR092; 6BR110; 6BR127; 6BR141; 6BR281
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Canada
  • Product Description
    Newton IQ 4 Lead Cycler Set with stay-safe patient connectors, used for acute and chronic peritoneal dialysis. || Catalog Number: 050-87028
  • Manufacturer
    Fresenius Medical Care North America

Manufacturer

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