Events

Retiro De Equipo (Recall) de ARCTICGEL Pads (used with the Arctic Sun Temperature Management System)

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-00234-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-03-03
  • 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-2016-RN-00234-1
  • 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 medical division (bmd) has received complaint reports of low flows associated with certain lots of the arcticgel pads. the clinical risk associated with the restricted/low flow arcticgel pads is suboptimal therapy delivery. in the event that one or more arcticgel pads do not have sufficient flow, the arcticgel pads may need to be exchanged. this may result in a slight delay in the therapy delivery which, if done in a timely manner, is not associated with long-term or residual clinical consequences. if alternate pads are not available, the patient may require therapy delivery by alternate means.
  • Acción
    Bard is advising users to inspect stock for the affected lot numbers. Any remaining affected product can be returned. This action has been closed-out on 30/01/2017.

Device

ARCTICGEL Pads (used with the Arctic Sun Temperature Management System)
  • Modelo / Serial
    ARCTICGEL Pads (used with the Arctic Sun Temperature Management System)Multiple Product Codes and Lot Numbers affectedARTG Number: 262560
  • Manufacturer
    Bard Australia Pty Ltd

Manufacturer

Bard Australia Pty Ltd