Events

Recall of FX CORDIAX HELIXONE PLUS HIGH-FLUX DIALYSER

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by FRESENIUS MEDICAL CARE CANADA 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
    139010
  • Event Risk Class
    II
  • Event Initiated Date
    2015-03-06
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    During the continuous post market surveillance of our fx cordiax dialyzers we have observed an increased number of cases of hypersensitivity and hypersensitivity-like reactions with the application of the fx cordiax dialyzers including life threatening events. these reactions occurred mainly both in the first treatment hour and within the first weeks of treatment with the fx cordiax dialyzers. the symptomatology varies and includes: dyspnoea chest congestion bronchospasm respiratory arrest hypotension tachycardia urticaria erythema flushing angioedema ocular hyperaemia pruritus abdominal pain nausea convulsions and unconsciousness.

Device

FX CORDIAX HELIXONE PLUS HIGH-FLUX DIALYSER
  • Model / Serial
    Model Catalog: F00002384 (Lot serial: NA); Model Catalog: F00001589 (Lot serial: NA); Model Catalog: F00001590 (Lot serial: NA); Model Catalog: F00001591 (Lot serial: NA); Model Catalog: F00001592 (Lot serial: NA); Model Catalog: F00001593 (Lot serial: NA); Model Catalog: F00001594 (Lot serial: NA); Model Catalog: F00001595 (Lot serial: NA); Model Catalog: F00001588 (Lot serial: NA)
  • Product Description
    FX CorDiax High-Flux dialyzers and FX CorDiax Haemodiafilters
  • Manufacturer
    FRESENIUS MEDICAL CARE CANADA INC.

Manufacturer

FRESENIUS MEDICAL CARE CANADA INC.