Events

Retiro De Equipo (Recall) de Peripheral interventional guides 0.018 Cordis (SV-5 and SV-8)

Según L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en France que fue producido por CORDIS SAS.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • Fecha
    2006-07-26
  • País del evento
    France
  • Fuente del evento
    ANSM
  • URL de la fuente del evento
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/retrait-de-lots-du-dm-guides-interventionnels-peripheriques-0-018-cordis-societe-cordis
  • Notas / Alertas
    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.
  • Notas adicionales en la data
  • Acción
    CORDIS SAS has withdrawn from the market on 25/07/2006 the batches indicated in the attached message of the medical device called Peripheral interventional guides 0.018 Cordis (SV-5 and SV-8) following the highlighting of a Possibility of fracture of the extremity, which can lead to a separation of the end of the guide. The company directly warned the recipients of the incriminated batch with the help of the attached message (25/07/2006) (23 ko ) This information is addressed to the directors of health establishments and the local correspondents of materiovigilance for diffusion, if necessary to the services concerned. The European competent authorities concerned are informed of this measure by the manufacturer. .

Device

Peripheral interventional guides 0.018 Cordis (SV-5 and SV-8)
  • Modelo / Serial
  • Descripción del producto
    medical_device
  • Manufacturer
    CORDIS SAS

Manufacturer

CORDIS SAS
  • Source
    LAANSM