Events

Retiro De Equipo (Recall) de Hickman and Leonard Central Venous Catheter Kits Multiple product codes affected

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Bard 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-2016-RN-00411-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2016-04-07
  • 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-2016-RN-00411-1
  • 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
    There is an incorrect expiration date on the product labelling for specific lots of hickman and leonard central venous catheter kits. the expiration date for the needle provided in these specific kits was not reflected in the unit or case expiration date label.
  • Acción
    Bard is advising users that affected stock can continue to be used in accordance with the corrected expiry dates provided with the recall letter. There is no requirement to return affected product. This action has been closed out on 25/01/2017.

Device

Hickman and Leonard Central Venous Catheter Kits Multiple product codes affected
  • Modelo / Serial
    Hickman and Leonard Central Venous Catheter Kits Multiple product codes affectedMultiple lot numbers affectedARTG numbers:145468 & 145469
  • Manufacturer
    Bard Australia Pty Ltd

Manufacturer

Bard Australia Pty Ltd