Events

Retiro De Equipo (Recall) de Bard ArcticSun ArticGel Pads

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-2017-RN-01405-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-11-17
  • 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-2017-RN-01405-1
  • 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
    The manufacturer, bard medical division (bmd), has identified specific lots of bard arcticsun articgel pads that have insufficient adhesion of the hydrogel to the pad, which has the risk of the hydrogel peeling away from pads during the removal of the release liner.
  • Acción
    Bard is providing customers with additional instructions for use to identify the potential issue, and provide guidance to allow the product to be used in a normal manner.

Device

Bard ArcticSun ArticGel Pads
  • Modelo / Serial
    Bard ArcticSun ArticGel PadsItem Code: 31700Lot/Serial Numbers: NGAW3898 and NGBP1302Item Code: 31705Lot/Serial Numbers: NGAZ2312 and NGBN2492Item Code: 31707Lot/Serial Numbers: NGBN3536ARTG Number: 262560 (Heating unit, pad, water)
  • Manufacturer
    Bard Australia Pty Ltd

Manufacturer

Bard Australia Pty Ltd