Events

Retiro De Equipo (Recall) de Ultra-Fine Insulin Syringe for use with U-100 insulin

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Becton Dickinson 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-2015-RN-01055-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-11-04
  • 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-2015-RN-01055-1
  • 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 blister package for some insulin syringes may exhibit an open seal potentially impacting on product sterility.No complaints or adverse events have been reported regarding this issue.
  • Acción
    Users are requested to inspect stocks on hand and to quarantine affected units pending collection of the affected stock. A replacement or suitable credit will then be issued. This action has been closed-out on 31/08/2016.

Device

Ultra-Fine Insulin Syringe for use with U-100 insulin
  • Modelo / Serial
    Ultra-Fine Insulin Syringe for use with U-100 insulinCatalogue Number: 326725 Lot Number: 5019750 ARTG Number: 125064
  • Manufacturer
    Becton Dickinson Pty Ltd

Manufacturer

Becton Dickinson Pty Ltd