Events

Retiro De Equipo (Recall) de Single Use Instruments including Scissors, forceps, and suckers

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Thermo Fisher Scientific 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-2018-RN-00153-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2018-02-19
  • 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-2018-RN-00153-1
  • 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
    Thermo fisher scientific received a labelling concern that a sterile instrument used during surgical procedures was not labelled as a single use instrument and that there could be the possibility of reuse.The devices affected are manufactured as single use instruments, and are safe for use as single use instruments. when used as single use instruments the devices do not pose a risk to human health and are safe to use within the scope of their artg inclusion.
  • Acción
    Thermo Fisher Scientific is advising users to keep the notification in a prominent position. The manufacturer is currently working with their notified body on a scope extension but due to the time required to complete this, a resolution may not be achieved for 6 to 12 months.

Device

Single Use Instruments including Scissors, forceps, and suckers
  • Modelo / Serial
    Single Use Instruments including Scissors, forceps, and suckersMultiple products affectedAll lots affected ARTG Numbers: 296281, 296277, 296279, 296278, 296276, 296280, 296240, 296260, 296315
  • Manufacturer
    Thermo Fisher Scientific Australia Pty Ltd

Manufacturer

Thermo Fisher Scientific Australia Pty Ltd