Events

Retiro De Equipo (Recall) de Merit/47258/Manifold Kits

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 Merit Medical Systems 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
    20513
  • Fecha de inicio del evento
    2016-08-24
  • 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: InterMed Medical Ltd, 71 Apollo Drive, Albany, AUCKLAND 1311
  • Causa
    Due to supplier moulding defect in the drip chamber prior to use and during prep, when contrast is drawn out of the contrast bottle air may be drawn into the contrast fluid channel from the vent channel resulting in the contrast having excessive air bubbles which can cause the burette to empty quickly and the blue ball to drop to the bottom of the chamber interfering with the contrast administration.
  • Acción
    Product to be returned to supplier

Device

Merit/47258/Manifold Kits

Manufacturer

Merit Medical Systems Inc