Events

Rappel de PTFE GRAFTS – ADVANT VXT, FLIXENE, FLIXENE w/IFG, ADVANTA SST with expiration between April 2017 and May 2018

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Atrium Australia - Pacific Rim Pty Limited.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2013-RN-00737-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2013-07-19
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00737-1
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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.
  • Action
    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 ...
  • Modèle / numéro de série
    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