Retiro De Equipo (Recall) de Veletri Consumables Kit with non Flow-Stop CADD Medication 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 Actelion Pharmaceuticals Australia 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-2017-RN-01369-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-10-30
  • 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
    Actelion pharmaceuticals australia (actelion) has been advised that certain non flow-stop cadd medication cassette reservoirs may have been manufactured with an incorrect pressure plate. specific veletri consumables kits contain affected non flow-stop cadd medication cassette reservoirs.Until replacement kits can be provided, it is recommended that the alternative flow-stop cadd medication cassette reservoirs are used.
  • Acción
    Actelion is advising users to inspect stock and quarantine affected stock. Affected stock can be returned to CH2 for replacement with unaffected stock.

Device

  • Modelo / Serial
    Veletri Consumables Kit with non Flow-Stop CADD Medication Cassette ReservoirsBatch Numbers: 0308836, 0309014, 0309014-2, 0309757, 0309991, 0000310729, 0000310798, 0000311083, 0000311167, 0000311170 and 0000311674ARTG Number: 219458 (Actelion Pharmaceuticals Australia Pty Ltd - Infusion administration set, infusion pump)
  • Manufacturer

Manufacturer