Retiro De Equipo (Recall) de Compounded Medications within CADD Medication Non-flow stop Cassette Reservoirs

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia 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
  • ID del evento
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notas adicionales en la data
  • Causa
    Baxter has been made aware of a recall initiated by smiths medical australasia of certain lots of 50 and 100ml cadd medication cassette reservoirs (non-flow stop) as they may have been manufactured with an incorrect pressure plate. baxter has identified some of the affected batches have been used to prepare compounded medications supplied to customers.
  • Acción
    Baxter Healthcare is advising users to inspect stock and quarantine affected units. Baxter are re-issuing required cassettes, if required.


  • Modelo / Serial
    Compounded Medications within CADD Medication Non-flow stop Cassette Reservoirs
  • Manufacturer