Events

Retiro De Equipo (Recall) de Of Spiggle & Thesis PTFE Ventilation Tubes - Fluoroplastic shepard button and Fluoroplastic collar button (Tympanostomy tubes used to ventilate the middle ear subsequent to otitis media)

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-2013-RN-00888-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-08-20
  • 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-2013-RN-00888-1
  • 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 primary packaging of the affected products could potentially have damage to the seal or seam. the sterility of the articles concerned is not guaranteed. it may not be possible for the user to identify this fault with absolute certainty.
  • Acción
    Customers are requested to quarantine the affected lots of product and organise with CoreMed for the return of any unused product.

Device

Of Spiggle & Thesis PTFE Ventilation Tubes - Fluoroplastic shepard button and Fluoroplastic colla...
  • Modelo / Serial
    Of Spiggle & Thesis PTFE Ventilation Tubes - Fluoroplastic shepard button and Fluoroplastic collar button (Tympanostomy tubes used to ventilate the middle ear subsequent to otitis media) Fluorplastic shepard button, 1.15mmRef.: 104115Lot numbers: 201208220750, 201210120800, 201211090450, 201302261000, 201301091000 and 201304121000Fluoroplastic collar button, 1.25mmRef.: 104125Lot number: 201301080700, 201302260700, A01210190500 and 201208130480ARTG Number: 182921
  • Manufacturer
    CoreMed Pty Ltd

Manufacturer

CoreMed Pty Ltd