Retiro De Equipo (Recall) de Extension Set(extension tubing for blood transfusion systems and standard intravenous administration sets)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por BMDi TUTA 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
    RC-2015-RN-00719-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-08-13
  • País del evento
  • Fuente del evento
    DHTGA
  • 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
    Bmdi tuta healthcare has been made aware of an issue with the female luer lock (fll) connector. when connected to the male luer lock (mll) connector of another device the fll may crack and subsequently leak. the reported incident rate is low and the fault has not been reproduced in house.
  • Acción
    BMDi TUTA is requesting the customers to inspect, discontinue use, and quarantine affected stock for replacement. BMDi TUTA is arranging for the return of any remaining stock

Device

  • Modelo / Serial
    Extension Set(extension tubing for blood transfusion systems and standard intravenous administration sets)REF 50.318H Lot No. 20141226ARTG Number 222156
  • Manufacturer

Manufacturer