Events

Retiro De Equipo (Recall) de Probe introducers distributed by GUIDANT

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 Guidant.

¿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
    2005-06-24
  • 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-d-introducteurs-de-sondes-distribues-par-guidant
  • 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
    The GUIDANT company has withdrawn from the market on June 20, 2005 the references and batches specified in the appendix of the medical devices called introducers (packaged under the GUIDANT or GUIDANT OSCOR brand) and provided for the introduction by venous approach of cardiac stimulation probes, in particular, difficulties encountered during the peeling of the introducer sheath. This recall follows a request from B.Braun Inc., the supplier of these introducers. The company has directly notified the recipients of the incriminated lots with the message attached (20/06/2005) (18 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.

Device

Probe introducers distributed by GUIDANT
  • Modelo / Serial
  • Descripción del producto
    medical_device
  • Manufacturer
    Guidant

Manufacturer

Guidant
  • Source
    LAANSM