Events

Retiro De Equipo (Recall) de Medtronic Navigator Passive Spheres

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 Northern Digital 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
    16614
  • Fecha de inicio del evento
    2014-05-06
  • 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: Medtronic New Zealand Limited, Unit 16 Mezzanine Level, 5 Gloucester Park Road, Onehunga, AUCKLAND
  • Causa
    A review of the medtronic internal returned goods procedures showed that there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage. this review identfied the sterile part numbers were processed through the returned goods procedures. a risk analysis was subsequently performed showing that, since there have been no complaints related to sterilisation/package damage there was no change in the likeihood of this scenario leading to harm. although there have been no reports of issues related to package sterile barrier damage, manufacturer has elected to issue this safety notice to address this possibility.
  • Acción
    Product to be returned to supplier

Device

Medtronic Navigator Passive Spheres
  • Modelo / Serial
    Model: Part Numbers: 8801071 & 8801075, Affected: Lot Numbers: 5 lots & 24 lots respectively
  • Manufacturer
    Northern Digital Inc

Manufacturer

Northern Digital Inc