Events

Recall of INFINITI 6 French selective diagnostic catheters

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 CORDIS EUROPA NV.

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
    2006-06-30
  • 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-de-catheters-diagnostiques-infiniti-de-la-societe-cordis
  • 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    The company CORDIS EUROPA NV has withdrawn from the market on June 28, 2006 the batches whose expiry date is between June 2008 and January 2009 of the references specified in the attached table, the medical device called "INFINITI 6 French selective diagnostic catheters" more a potential risk of detachment of the end .. The company has directly notified the recipients of the incriminated lots with the message attached (28/06/2006) (39 KB) validated by Afssaps. Information is addressed to the directors of health establishments and the local correspondents of materiovigilance for dissemination, where appropriate to the services concerned. The competent European authorities concerned are informed of this measure by the manufacturer.

Device

INFINITI 6 French selective diagnostic catheters
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    CORDIS EUROPA NV

Manufacturer

CORDIS EUROPA NV
  • Source
    LAANSM