Events

Recall of PREFACE introducers

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 BIOSENSE WEBSTER / CORDIS.

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
    2006-12-19
  • 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-lots-d-introducteurs-preface-de-la-societe-biosense-webster
  • 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
    BIOSENSE WEBSTER / CORDIS withdrew from the market on December 15, 2006 all lots of references 301803MS, 301803M, 301805M, 301803A, 301803P of the medical device called "PREFACE introducers" following claims of partial separation or detachment of the medical device. radiopaque end, which may lead to embolisms. The company has directly notified the recipients of the incriminated references using the message attached (15/12/2006) (27 KB) validated by Afssaps. This information is addressed to the directors of health establishments and local correspondents of materiovigilance for dissemination, where appropriate to the services concerned. the relevant European Competent Authorities are informed of this measure by the manufacturer.

Device

PREFACE introducers

Manufacturer

BIOSENSE WEBSTER / CORDIS
  • Source
    LAANSM