Events

Retiro De Equipo (Recall) de Hudson Nebuliser Adaptor - AQUAPAK

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Teleflex Medical 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-2014-RN-01103-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-10-10
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01103-1
  • 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
    Teleflex medical has initiated this recall due to the possibility that the seals of the adaptor packaging may be creased which may potentially affect packaging integrity and the sterility of the adaptor.
  • Acción
    Teleflex Medical is advising the customers to immediately discontinue use and quarantine all affected units. Teleflex Medical customer service will arrange for the collection and replacement of the affected units or provide a credit note. This acton has been closed-out on 02/05/2017.

Device

Hudson Nebuliser Adaptor - AQUAPAK
  • Modelo / Serial
    Hudson Nebuliser Adaptor - AQUAPAKProduct Codes: HUD403728, HUD404428Lot numbers: HUD403728 – 100130HUD404428 - 039134ARTG Number: 215829
  • Manufacturer
    Teleflex Medical Australia Pty Ltd

Manufacturer

Teleflex Medical Australia Pty Ltd