Events

Recall of AV-Set FMC line (FA 204 C / FV 204E) BVM

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
    Recall
  • Date
    2004-08-27
  • Event Country
    France
  • Event Source
    ANSM
  • Event Source URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/retrait-de-lot-de-ligne-de-dialyse-de-la-societe-fresenius-medical-care
  • 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
    In agreement with Afssaps, the company Fresenius Medical Care withdraws from the market the batch LEG182 (sublots LEG182 00 and LEG182 01) of the reference 5016631 of the medical device called AV-Set FMC line (FA 204 C / FV 204E) BVM following several reports of blood leakage in the venous bubble trap .. The 15 health facilities concerned by this recall are notified directly by means of the message attached (27/08/2004) (51 KB).

Device

AV-Set FMC line (FA 204 C / FV 204E) BVM

Manufacturer

Fresenius Medical Care