Events

Retiro De Equipo (Recall) de Of Spiggle & Theis PTFE Ventilation Tubes

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por CoreMed 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-2014-RN-00835-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-07-31
  • 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-2014-RN-00835-1
  • 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
    Spiggle & theis medizintechnik gmbh internal routine checks discovered that the weld seam of the blister packaging might be incomplete in the area of the pull tab.The weld seam around the blister cavity might show a visually inconsistent blue colouring. this may impair the sterility of the product.
  • Acción
    CoreMed is advising their customers not to use the blisters where the sterile barrier appears to be impaired i.e., the weld seam of the blister packaging might be incomplete in the area of the pull tab and return them to CoreMed. CoreMed will replace the affected products. This action has been closed-out on 02/06/2016.

Device

Of Spiggle & Theis PTFE Ventilation Tubes
  • Modelo / Serial
    Of Spiggle & Theis PTFE Ventilation TubesArticle Numbers: 104100, 104115, 104125Multiple batch numbers affectedARTG Number: 182921
  • Manufacturer
    CoreMed Pty Ltd

Manufacturer

CoreMed Pty Ltd