Events

Retiro De Equipo (Recall) de Bolton Surgical - Sims Speculum D/E Insulated Large 33 x 38 mm 18.5cm

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Device Technologies 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-2012-RN-00951-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2012-09-21
  • 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-2012-RN-00951-1
  • 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
    It has been identified that there is a possible fault in the affected batches due to inadequate bonding between the coating and substrate in manufacturing, which may cause insulation to crack and lift away from the metal body.
  • Acción
    Customers to identify and segregate any units from affected batch number and contact the sponsor to arrange return of recalled stock and order replacement stock.

Device

Bolton Surgical - Sims Speculum D/E Insulated Large 33 x 38 mm 18.5cm
  • Modelo / Serial
    Bolton Surgical - Sims Speculum D/E Insulated Large 33 x 38 mm 18.5cmProduct Code: ENG-17/1847/6Batch/Lot Number: 117696ARTG Number: 175488
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd