Events

Retiro De Equipo (Recall) de Baxter Clearlink System Buretrol Solution Set with 150ml Clearlink Burette

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 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
    13450
  • Fecha de inicio del evento
    2012-09-05
  • 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
    Baxter has determined that the ball-valve feature may not function as expected, allowing air to flow past the valve and into the tubing at the completion of dose within the burette. baxter has not received reports of patient injuries or adverse events as a result of the improper function of the ball-valve.
  • Acción
    Product to be returned to supplier

Device

Baxter Clearlink System Buretrol Solution Set with 150ml Clearlink Burette

Manufacturer

Baxter Healthcare Corporation