Events

Retiro De Equipo (Recall) de Zenith Branch Iliac Endovascular Graft (ZBIS) - Patient Card

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por William A Cook 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-2018-RN-00118-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2018-02-07
  • 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-2018-RN-00118-1
  • 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
    Cook medical has become aware that an incorrect patient card may have been included in the zenith branch endovascular graft - iliac bifurcation (zbis) devices supplied between november 2017 and january 2018. the device name on the incorrect patient card is zenith p-branch and the mri image artefact radius specified on the zbis patient card is slightly different from the image artefact radius on the incorrect patient card. the patient card is the only portion of the product impacted, there is no impact on the packaged device.There have been no customer complaints received to date in regards to this issue.
  • Acción
    Cook Medical is providing replacement patient cards to all affected customers.

Device

Zenith Branch Iliac Endovascular Graft (ZBIS) - Patient Card
  • Modelo / Serial
    Zenith Branch Iliac Endovascular Graft (ZBIS) - Patient CardReference Part Numbers: ZBIS-12-61-41, ZBIS-12-45-41, ZBIS-12-45-58, ZBIS-12-61-58, ZBIS-10-61-58, ZBIS-10-45-41, ZBIS-10-61-41Multiple lot numbers affectedARTG Number: 138930
  • Manufacturer
    William A Cook Australia Pty Ltd

Manufacturer

William A Cook Australia Pty Ltd