Events

Retiro De Equipo (Recall) de Portex Thoracic Catheter and Connecting 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 Smiths Medical Australasia 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-00357-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2018-04-24
  • 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-00357-1
  • 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
    Smiths medical became aware of a potential breach in the seal of the package on certain packaging lots. these packages were used in the manufacturing of certain portex thoracic catheters and connecting tubes, compromising the sterility of the devices. smiths medical has not received any reports of serious injury relating to this issue.
  • Acción
    Smiths Medical is advising customers to quarantine all stock of the affected units. Upon receipt of a completed Response Form provided with the Customer Letter, a Smiths Customer Service Representative will contact users with a Return Material Authorisation Number to facilitate the return of the product and issue a credit.

Device

Portex Thoracic Catheter and Connecting Tube
  • Modelo / Serial
    Portex Thoracic Catheter and Connecting TubeThoracic Catheter 28Fangled Soft, Adult Connector, 10/CAModel Number: 200/812/280Multiple Lot NumbersARTG Number: 145749Smiths Medical Australasia - Portex Thoracic Catheter - Drain, thoracic
  • Manufacturer
    Smiths Medical Australasia Pty Ltd

Manufacturer

Smiths Medical Australasia Pty Ltd