Events

Retiro De Equipo (Recall) de Suction Tube

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por ConvaTec 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-00514-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-06-17
  • 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-00514-1
  • 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
    An internal assessment of product complaints has confirmed that these devices are not meeting the manufacturer's specifications. specifically, the connector part for application to the suction devices in these lots, has failed to meet its required reliability. the connector parts of the specified lots have a higher probability to crack once applied to suction devices outlets.
  • Acción
    Convatec is requesting end users to quarantine the affected product and return to their distributor for replacement or credit. This action has been closed-out on 11/08/2016.

Device

Suction Tube
  • Modelo / Serial
    Suction TubeSterile Codes: 530.25.200, 530.25.300, 530.25.450, 530.25.600, 530.25.800, 530.30.200, 530.30.300, 530.30.450, 530.30.600, 533.30.300Non-sterile Codes: 533.25.050, 533.25.100, 533.25.150, 533.25.200, 533.25.300, 533.25.450, 533.25.600Multiple BatchesARTG Numbers: 173916 (Sterile) & 204281 (Non-sterile)
  • Manufacturer
    ConvaTec Australia Pty Ltd

Manufacturer

ConvaTec Australia Pty Ltd