Recall of Hemodialyzer - Polyflux Revaclear / Revaclear Max

According to L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), this recall involved a device in France that was produced by Gambro.

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
  • Event ID
  • Date
  • Event Country
  • Event Source
  • Event Source URL
  • Notes / Alerts
    French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), 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 France.
  • Extra notes in the data
  • Action
    The ANSM has been informed of the implementation of a recall made by the company Gambro. The centers concerned users have received the attached mail (24/11/2014) (1045 KB). This safety action is registered with the ANSM under the number 201415458 .. You will be able to consult its progress report on the Directory of the signaling of materialovigilanc. by entering this registration number.


  • Model / Serial
  • Product Description
  • Manufacturer