Events

Retiro De Equipo (Recall) de Rocket IPC Drainage System

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 Rocket Medical PLC.

¿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
    17559
  • Fecha de inicio del evento
    2014-10-31
  • 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: Universal Specialities Ltd trading as USL Medical, 494 Rosebank Road, Avondale, AUCKLAND 1026
  • Causa
    A small number of drainage bottles have appeared to malfunction as the blue connector tube has not opened once the white clip has been moved. the non-opening of the blue tube does not allow the vacuum contained in the bottle to initiate drainage of fluid from the patient.
  • Acción
    Manufacturer to issue advice regarding use

Device

Rocket IPC Drainage System
  • Modelo / Serial
    Model: R54400, R54400-00-PP, R54410, R51400, R51400-00-PP, R51410, Affected:
  • Manufacturer
    Rocket Medical PLC

Manufacturer

Rocket Medical PLC