Events

Retiro De Equipo (Recall) de Arceole C3F8 and SF6

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-2015-RN-01106-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2015-11-11
  • 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-01106-1
  • 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
    There is a possibility that 2 units of c3f8 (lot 15052502) have been incorrectly packaged in sf6 boxes. the product codes for these items are as-c3f8 and as-sf6 respectively. however, the box label, the blister label, the patient labels and the canister would be properly labelled as c3f8. there is a remote risk that the user may not identify the mislabelling before use, and incorrectly use the c3f8 gas at a concentration usually used for the sf6, which would be a maximum of 20% instead of 12%.
  • Acción
    Sponsor to notify potentially affected customers. Customers to inspect and return affected sotck. Sponsor to replace affected stock. This action has been closed-out on 24/08/2016.

Device

Arceole C3F8 and SF6

Manufacturer

Device Technologies Australia Pty Ltd