Events

Retiro De Equipo (Recall) de Back Table Cover supplied in a limited range of Operating Room Packs

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Plus Medical 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-00686-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-07-24
  • 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-00686-1
  • 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
    Itl healthcare has identified an issue as a result of one customer complaint with the standard back table cover from one supplier. once the outer bag is opened the back table cover serves as a trolley cover. in some instances the sterility will be breached if the permeability of the back table cover is challenged. this issue was not observed in all batches; the extent is still under investigation.
  • Acción
    ITL Healthcare is providing workaround instructions to be undertaken during surgery setup. Alternative Back Table Covers will be provided free of charge to facilitate the workaround. Should the hospital be unable to implement the workaround, ITL will provide replacement Operating Room Packs. This action has been closed-out on 15/08/2016.

Device

Back Table Cover supplied in a limited range of Operating Room Packs
  • Modelo / Serial
    Back Table Cover supplied in a limited range of Operating Room Packs
  • Manufacturer
    Plus Medical Pty Ltd

Manufacturer

Plus Medical Pty Ltd