Recall of AV Set FMC dialysis lines

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 Fresenius Medical Care.

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
  • 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
    On October 15, 2004, the company Fresenius Medical Care withdrew from the market several batches of references 5017531 and 5017851 of the medical device called AV Set FMC dialysis lines following several reports of blood leakage in the arterial chamber. health concerned by this recall are warned directly by means of the message attached (18/10/2004) (13 KB) validated by Afssaps. This information is addressed to the local correspondents of materiovigilance and to the directors for diffusion to the concerned services. The other European competent authorities have not been informed, this measure only concerning France .. Courrier Fresenius Medical Care (18/10 / 2004) (13 KB)