Events

Retiro De Equipo (Recall) de Biosense Webster ThermoCool SmartTouch Uni-Directional Catheter

Según New Zealand Medicines and Medical Devices Safety Authority, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en New Zealand que fue producido por Biosense Webster Inc.

¿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
  • ID del evento
    15358
  • Fecha de inicio del evento
    2013-09-12
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: Johnson & Johnson Medical New Zealand Ltd, 507 Mt Wellington Highway, Mt Wellington, AUCKLAND 1060
  • Causa
    An investigation identified a defect in the production process which can lead to occlusion of the irrigation fluid lumen. to date, there have been no patient injuries or adverse events reported as a result of this defect.
  • Acción
    Product to be returned to supplier

Device

Biosense Webster ThermoCool SmartTouch Uni-Directional Catheter
  • Modelo / Serial
    Model: Product Code D132701, D132702, D132703, D132704, D132705, D133601, D133602, D133603, Affected: All lots
  • Manufacturer
    Biosense Webster Inc

Manufacturer

Biosense Webster Inc