Events

Retiro De Equipo (Recall) de PTFE GRAFTS – ADVANT VXT, FLIXENE, FLIXENE w/IFG, ADVANTA SST with expiration between April 2017 and May 2018

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Atrium Australia - Pacific Rim Pty Limited.

¿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-00737-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-07-19
  • 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-2013-RN-00737-1
  • 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
    Atrium medical has become aware that the label on the tab of the inner tyvek cover can adhere, to the inside wall of the outer tray. this may make it more difficult to employ the user's current technique which is to first pass the inner tray from the outer tray and then onto the sterile field. in some cases, because of the sticking of the inner tray to the outer tray, it has been reported that the inner tray must be lifted from the outer tray.
  • Acción
    Atrium medical are advising users of work around instructions to follow to prevent the issue from occurring.

Device

PTFE GRAFTS – ADVANT VXT, FLIXENE, FLIXENE w/IFG, ADVANTA SST with expiration between April 2017 ...
  • Modelo / Serial
    PTFE GRAFTS – ADVANT VXT, FLIXENE, FLIXENE w/IFG, ADVANTA SST with expiration between April 2017 and May 2018Multiple catalogue and lot numbers affectedARTG Numbers: 154085, 155155, 155159, 155171, 154087, 155157, 155158, 155161, 155168, 155957, 176909, 155225, 182788
  • Manufacturer
    Atrium Australia - Pacific Rim Pty Limited

Manufacturer

Atrium Australia - Pacific Rim Pty Limited
  • Source
    DHTGA