Events

Rappel de Single Use Instruments including Scissors, forceps, and suckers

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Thermo Fisher Scientific Australia Pty Ltd.

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-2018-RN-00153-1
  • Classe de risque de l'événement
    Class III
  • Date de mise en oeuvre de l'événement
    2018-02-19
  • 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-2018-RN-00153-1
  • 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
    Thermo fisher scientific received a labelling concern that a sterile instrument used during surgical procedures was not labelled as a single use instrument and that there could be the possibility of reuse.The devices affected are manufactured as single use instruments, and are safe for use as single use instruments. when used as single use instruments the devices do not pose a risk to human health and are safe to use within the scope of their artg inclusion.
  • Action
    Thermo Fisher Scientific is advising users to keep the notification in a prominent position. The manufacturer is currently working with their notified body on a scope extension but due to the time required to complete this, a resolution may not be achieved for 6 to 12 months.

Device

Single Use Instruments including Scissors, forceps, and suckers
  • Modèle / numéro de série
    Single Use Instruments including Scissors, forceps, and suckersMultiple products affectedAll lots affected ARTG Numbers: 296281, 296277, 296279, 296278, 296276, 296280, 296240, 296260, 296315
  • Manufacturer
    Thermo Fisher Scientific Australia Pty Ltd

Manufacturer

Thermo Fisher Scientific Australia Pty Ltd