Events

Retiro De Equipo (Recall) de TXR-ME (Tri-Ex Extraction Balloon with Multiple Sizing)(275 cm Length only)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por William A Cook 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-00795-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-07-18
  • 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-00795-1
  • 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
    Cook medical has received complaints that some tri-ex extraction balloons may not fit through endoscopes with a 2.8 mm channel. the extraction balloon is labelled for use with a 2.8 mm endoscope.
  • Acción
    Cook medical is requesting their customers to review their stock for the affected lot numbers and quarantine any affected product in preparation for return. This action has been closed-out on 03/06/2016.

Device

TXR-ME (Tri-Ex Extraction Balloon with Multiple Sizing)(275 cm Length only)
  • Modelo / Serial
    TXR-ME (Tri-Ex Extraction Balloon with Multiple Sizing)(275 cm Length only) Serial Numbers: W3372236(1), W3376524(1), W3427509(2), W3406080(1), W3388883(2), W3403192(2), W3334395(1), W3374821(1), W3376524(1), W3308765(2), W3333058(2), W3415262(2)ARTG number: 133685
  • Manufacturer
    William A Cook Australia Pty Ltd

Manufacturer

William A Cook Australia Pty Ltd