Retiro De Equipo (Recall) de Baxter Colied Tube INFUSOR System cs

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
    16553
  • Fecha de inicio del evento
    2014-04-17
  • País del evento
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
  • 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
    Manufacturer has received complaints for infusion flow rates greater than intended for the listed portable elastomeric infusion systems. manufacturer is requesting that healtrhcare providers consider the instructions for use which explain facts that may impact resulting flow rate., point #5 of the instructions for use is incorrect and manufactrer will be making a change to this to reflect this information.
  • Acción
    Instructions for use to be updated

Device

  • Modelo / Serial
    Model: 2C1071KJP 1C1071KJ 1C1073KJP 2C1075KJP 2C1080KJP 2C1082KJP and 2C1082KJ, Affected:
  • Manufacturer

Manufacturer