Events

Retiro De Equipo (Recall) de 5mm ENDOPATH XCEL Trocars with Optiview Technology

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Johnson & Johnson Medical 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-2018-RN-00284-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2018-04-05
  • 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-2018-RN-00284-1
  • 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
    Johnson & johnson medical has been advised that the manufacturer, ethicon, has become aware of reports from customers related to difficulty removing the obturator from the 5mm endopath xcel trocars with optiview technology.To date, no injuries have been reported as a result of this issue.
  • Acción
    Johnson & Johnson Medical is advising users to inspect stock for affected product. Users should complete the Response Form provided with the Customer Letter to arrange for return and replacement of affected goods.

Device

5mm ENDOPATH XCEL Trocars with Optiview Technology
  • Modelo / Serial
    5mm ENDOPATH XCEL Trocars with Optiview TechnologyBladeless 5x100 StabilityProduct Code 2B5LTBatch Numbers: P4T58Y, P4T665, P4T83K, P4T88G, P4T927, R4000W, R4004GBladeless 5X75 StabilityProduct Code 2B5STBatch Numbers: P4T745, P4T906, P4T91HSleeve 5x100 StabilityProduct Code 2CB5LTBatch Numbers: P4T636, P4T63G, P4T708, P4T89NSleeve 5x75 StabilityProduct Code 2CB5STBatch Numbers: P4T686, P4T99K,P4T79AExpiry: between Sep 2022 - Jan 2023ARTG: 108472, 108482
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd

Manufacturer

Johnson & Johnson Medical Pty Ltd