Events

Retiro De Equipo (Recall) de Vygon SA – Y connector code 884.08(tubing connector)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Device Technologies 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-2015-RN-00634-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2015-07-15
  • 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-2015-RN-00634-1
  • 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
    Vygon has identified a manufacturing defect, which could result in blockage of the y-connector. this obstruction cannot be visually detected by the end user before use.
  • Acción
    Device Technologies are requesting users read this notice in full and distribute to all relevant personnel and to inspect their inventory and isolate any of Vygon Y Connector with product code VY-884.08 and lot number 100315EG and to complete the attached Reply Fax Form. This action has been closed-out on 31/08/2016.

Device

Vygon SA – Y connector code 884.08(tubing connector)

Manufacturer

Device Technologies Australia Pty Ltd