Events

Retiro De Equipo (Recall) de Lifemed Urinary Drainage Bag with Pump

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-2014-RN-01058-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-10-03
  • 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-2014-RN-01058-1
  • 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 australia has received nine (9) reports of the bard australia lifemed urinary drainage bag being incorrectly assembled with the bulb located in the wrong position. incorrect positioning of the bulb in relation to the inlet tube makes it more difficult to use to the product for its intended purpose. no reports of injuries or harm to the patient or user have been reported.
  • Acción
    Customers are advised to check all inventory locations within their institution for the affected stock and segregate these items from their inventory for returning to Bard Australia. This action has been closed-out on 01/03/2016.

Device

Lifemed Urinary Drainage Bag with Pump
  • Modelo / Serial
    Lifemed Urinary Drainage Bag with PumpProduct Code: L153514Lot Number: NGXL1240ARTG Number: 163481
  • Manufacturer
    Bard Australia Pty Ltd

Manufacturer

Bard Australia Pty Ltd