Events

Retiro De Equipo (Recall) de Bard Rival PTA Catheters

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-2015-RN-00602-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-07-15
  • 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-00602-1
  • 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
    A portion of the affected lot contains units with an incorrect compliance card affixed to the catheter hoop inside the product pouch. specifically, the incorrect 7mm compliance card contains the incorrect balloon diameter, lengths, diameter growth (compliance), and rated burst pressure (rbp) information instead of the correct 6mm compliance card.
  • Acción
    End users are advised of the labelling issue and provided with the correct compliance card. Bard is recommending that the affected stock is isolated and that this letter is placed in a prominent positon with the isolated stock.

Device

Bard Rival PTA Catheters
  • Modelo / Serial
    Bard Rival PTA Catheters Product code RV135610 lot # GFYG3726 onlyARTG#: 172107
  • Manufacturer
    Bard Australia Pty Ltd

Manufacturer

Bard Australia Pty Ltd