Events

Retiro De Equipo (Recall) de Secure System and Kids Kit Collection Sites

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 Medex Medical.

¿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
    2004-10-25
  • 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-de-site-de-prelevement-secure-system-et-kids-kit-de-medex-medical
  • 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
    On October 22, 2004, the company Medex Medical withdrew from the market the references and batches specified in the attached list (25/10/2004) (9 ko) in annex of the medical device called "Secure System" and "Kids Kit" site sampling due to a risk of development of fracture lines in the body of this site, which can weaken the whole and cause dislodgment of the septum .. No report has been reported in Europe to date. The Medex Medical company warned the users directly with the attached message (25/10/2004) (12 KB) validated by Afssaps. This information is addressed to the directors and local correspondents of materiovigilance for diffusion to the services concerned. The relevant European Competent Authorities are informed of this measure by the manufacturer. list of references and lots (25/10/2004) (9 ko message Medex Medical (25/10/2004) (12 ko)

Device

Secure System and Kids Kit Collection Sites
  • Modelo / Serial
  • Descripción del producto
    medical_device
  • Manufacturer
    Medex Medical

Manufacturer

Medex Medical
  • Source
    LAANSM