Events

Retiro De Equipo (Recall) de HANAROSTENT Biliary Stent

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 MITech Co., Ltd.

¿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
    2008-04-25
  • 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-du-dispositif-stent-biliaire-hanarostent-avec-introducteur-de-diametre-7-f-societe-life-partners-europe
  • 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    On 24/04/08, Life Partners Europe has withdrawn from the market the batches of the references contained in the enclosed message of the medical device known as HANAROSTENT Biliary Stent with Introducer of 7 F diameter manufactured by MITech Co., Ltd., following two incidents in Asia in which the external catheter broke off the introducer during the procedure. Such an incident is patient-free because it appears in the 1st stage of the procedure, before implantation of the prosthesis when the device can be totally removed from the endoscope. Life Partners Europe has directly notified the recipients of the offending lots by means of the attached message (25/04/2008) (37 KB) validated by Afssaps. This information is addressed to the directors, correspondents of materiovigilance and pharmacists for diffusion if necessary to the services concerned. The relevant European Competent Authorities are informed of this measure by the manufacturer.

Device

HANAROSTENT Biliary Stent
  • Modelo / Serial
  • Descripción del producto
    medical_device
  • Manufacturer
    MITech Co., Ltd

Manufacturer

MITech Co., Ltd
  • Source
    LAANSM