Events

Retiro De Equipo (Recall) de Bard StatLock Catheter Stabilisation Device

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-01605-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-12-13
  • 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-01605-1
  • 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
    Bard access systems has recently become aware that some statlock catheter stabilisation device single unit pouches have been released without unique product identifiers (product code, lot number, expiration date, etc.).If the statlock were used beyond its expiration date and became unstable, it may provide sub-optimal securement or stabilisation.
  • Acción
    Customers who have purchased the affected stock are being provided with the missing unique product identifiers (product code, lot number, expiration date, etc.). This action has been closed-out on 25/05/2017.

Device

Bard StatLock Catheter Stabilisation Device
  • Modelo / Serial
    Bard StatLock Catheter Stabilisation Device Product Code: CV0220Lot Number: JUAPF369Expiry Date: 31-Jan-2019ARTG Number: 141586
  • Manufacturer
    Bard Australia Pty Ltd

Manufacturer

Bard Australia Pty Ltd