Events

Retiro De Equipo (Recall) de NovoPen Echo

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 Novo Nordisk A/S.

¿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
    21652
  • Fecha de inicio del evento
    2017-07-04
  • 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: Novo Nordisk Pharmaceuticals Ltd, 58 Richard Pearse Drive, Airport Oaks, Auckland
  • Causa
    The manufacturer has detected that the insulin cartridge holder used in a small number of novopen echo batches may crack or break if exposed to certain chemicals, for example certain cleaning agents. however when cleaning the pen as described in the novopen echo user guide, there is no reason to believe that cracking of the cartridge holder will occur.
  • Acción
    Product to be returned to supplier

Device

NovoPen Echo
  • Modelo / Serial
    Model: , Affected: Batch Numbers, EVG3310-6, EVG4252-2, FVG8412-3, FVG8415-1
  • Manufacturer
    Novo Nordisk A/S

Manufacturer

Novo Nordisk A/S