Events

Recall of OPTIFLUX HEMODIALYZERS

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
    120572
  • Event Risk Class
    II
  • Event Initiated Date
    2011-02-16
  • 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
    Since october 28 2010 fmcna-rtg has received reports of 19 incidents of internal blood leaks for optiflux f250nre hemodialyzer lot 10hu02012.Quality trending analysis has revealed that lot 10hu02012 demonstrated a higher blood leak rate than for lots proceeding and following lot 10hu02012. same thing for the lot 10lu2016.

Device

OPTIFLUX HEMODIALYZERS
  • Model / Serial
    Model Catalog: 0500325E (Lot serial: 10HU02012); Model Catalog: 0500325E (Lot serial: 10LU02016)
  • Product Description
    OPTIFLUX F250NRe DIALYZERS
  • Manufacturer
    FRESENIUS MEDICAL CARE CANADA INC.

Manufacturer

FRESENIUS MEDICAL CARE CANADA INC.