Events

Retiro De Equipo (Recall) de PORT-A-CATH Plastic Hub Needles, 0.9mm (20G) x 19mm (3/4 in) 90 deg

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-2015-RN-00944-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-09-25
  • 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-00944-1
  • 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 has become aware of a labelling issue with one lot of port-a-cath plastic hub needles. the label on the lid stock of the individual needle package lists the incorrect product reorder number, description and product image. the product reorder number should be 21-2287-24 with a corresponding description and product image, but instead it lists the 21-2005-24 product reorder number, description and product image. the needle inside the individual package is the product reorder no. 21-2287-24 needle and the outer carton label lists the correct reorder number 21-2287-24.
  • Acción
    Smiths Medical is advising customers to quarantine affected stock. Any affected stock will be replaced or a credit issued.

Device

PORT-A-CATH Plastic Hub Needles, 0.9mm (20G) x 19mm (3/4 in) 90 deg
  • Modelo / Serial
    PORT-A-CATH Plastic Hub Needles, 0.9mm (20G) x 19mm (3/4 in) 90 degProduct re-order Number: 21-2287-24Lot Number: 46262ARTG Number: 145298
  • Manufacturer
    Smiths Medical Australasia Pty Ltd

Manufacturer

Smiths Medical Australasia Pty Ltd