Events

Safety Alert for FX CorDiax Haemodiafilters and FX CorDiax High Flux dialysers

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Fresenius Medical Care.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2015-03-09
  • Event Date Posted
    2015-03-09
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150308.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: fresenius medical care fx cordiax haemodiafilters and fx cordiax high flux dialysers medical device manufacturer, fresenius medical care, has issued a medical device safety alert concerning fx cordiax haemodiafilters and fx cordiax high flux dialysers [reference numbers: f00001593, f00001594, f00001595, f00001588, f00001589]. the manufacturer has observed an increase in number of cases of hypersensitivity and hypersensitivity-like reactions during haemodialysis and haemodiafiltration treatments. these reactions occurred mainly in the first treatment hour or within the first week of treatment, and are potentially life threatening. the manufacturer is advising users to carefully monitor patients who have not been treated with the affected device or have a history of allergy or asthma. patients with known hypersensitivity to any of the dialyser’s materials must not be treated with the dialysers. if severe hypersensitivity and hypersensitivity-like reactions occur, the dialysis must be discontinued and the blood from the extracorporeal system must not be returned to the patient. the manufacturer has also updated the instructions for use. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 9 march 2015.

Device

FX CorDiax Haemodiafilters and FX CorDiax High Flux dialysers
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Fresenius Medical Care FX CorDiax Haemodiafilters and FX CorDiax High Flux dialysers
  • Manufacturer
    Fresenius Medical Care

Manufacturer

Fresenius Medical Care