Events

Retiro De Equipo (Recall) de Cordis PRECISE PRO Rx Nitinol Stent System

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 Cordis Corporation.

¿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
    20148
  • Fecha de inicio del evento
    2016-05-11
  • 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
    Based on complaints and subsequent investigation, the manufacturer has detected an increased frequency of users reporting difficulty with stent deployment and/or separation of the bond between sections of the device outer member., the manufacturer has isolated the issue to product manufactured between april 27, 2015 and november 22, 2015. product that has been manufactured after november 22, 2015, is not affected.
  • Acción
    Product to be destroyed

Device

Cordis PRECISE PRO Rx Nitinol Stent System
  • Modelo / Serial
    Model: Multiple lot numbers, Affected: Product manufactured between April 27, 2015 and November 22, 2015.
  • Manufacturer
    Cordis Corporation

Manufacturer

Cordis Corporation