Retiro De Equipo (Recall) de Exchange of Adapters for Mono and Dual Cath Catheters

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 HEMOTECH.

¿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
    2005-07-13
  • País del evento
  • Fuente del evento
    ANSM
  • URL de la fuente del evento
  • 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 Afssaps was informed on July 6, 2005 by the company HEMOTECH of an exchange of external adapters for Mono or Dual Cath catheters following several cases of rupture at the connection piece, due to asperities weakening the silicone. The manufacture of adapters has been modified since June 15, 2005; the new devices, starting from lot MABX130 no longer present this risk .. The concerned users were warned directly by means of the enclosed mail (13/07/2005) (50 KB), sent on June 30, 2005, asking them to replace the adapters contained in the trays with the catheters, by modified devices sent in exchange. This information concerns the directors of health establishments and the local correspondents of materiovigilance for diffusion to the services of hemodialysis, of nephrology, resuscitation, surgery, operating theaters and pharmacies of hospitals .. This device has been marketed in France.

Device

  • Modelo / Serial
  • Descripción del producto
    medical_device
  • Manufacturer

Manufacturer

  • Source
    LAANSM