Events

Retiro De Equipo (Recall) de Baxter 0.9% Sodium Chloride for Iirrigation

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 Baxter Healthcare Pty Ltd.

¿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
    18355
  • Fecha de inicio del evento
    2015-04-13
  • 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: Baxter Healthcare Ltd, 33 Vestey Drive, Mt Wellington, AUCKLAND
  • Causa
    An investigation into an adverse event report concering a 6l renal dialysis solution that affected a single patient revealed the solution had been diluted. manufacturer is recalling the products listed as further investigation revealed that these products were also potentially diluted with water for injection.
  • Acción
    Product to be returned to supplier

Device

Baxter 0.9% Sodium Chloride for Iirrigation

Manufacturer

Baxter Healthcare Pty Ltd