Events

Retiro De Equipo (Recall) de DYONICS 25

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 SMITH and NEPHEW.

¿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
    2009-06-04
  • 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/rappel-de-tubulures-pour-systeme-dyonics-25-smith-et-nephew
  • 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 02/06/09, the company SMITH and NEPHEW removed from the market the batches of the references cited in the attached recall message of the named medical devices (tubings). DYONICS 2. Fluid Management System Disposable Inflow / Outflow Tubeset With Single Suctio. Disposable inlet / outlet manifold for fluid management system (simple suction) DYONICS 2. Fluid Management System Disposable Inflow / Outflow Tubeset With Forked Suctio Disposable inlet / outlet tubing for fluid management system (suction in This recall follows a manufacturing defect of the plastic trays in which these pipes are conditioned.This manufacturing defect can potentially compromise the sterility of these pipes.The company SMITH and NEPHEW directly warned the recipients of the batches in question. the attached message (04/06/2009) (24 ko) validated by Afssaps This information is addressed to the directors and correspondents of materiovigilance for diffusion if necessary to the services concerned.

Device

DYONICS 25
  • Modelo / Serial
  • Descripción del producto
    medical_device
  • Manufacturer
    SMITH and NEPHEW

Manufacturer

SMITH and NEPHEW
  • Source
    LAANSM