Events

Rappel de Gynecare Thermachoice III Thermal Balloon Ablation Silicone Catheter

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Johnson & Johnson Medical 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-2015-RN-01186-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-12-10
  • 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-2015-RN-01186-1
  • 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
    This product is being removed from the market as stability data does not substantiate the labelled two-year shelf life of affected product.The affected units may fail prematurely before the labelled two-year shelf life. the failure may be manifested by pinhole leak, hexcap crack leak and tri-y manifold crack leak. these types of leakage may potentially result in the abortion of the procedure, temporary thermal injury to the cervix and/or vagina and in some cases additional surgical procedures.
  • Action
    The sponsor is advising users to inspect stock and quarantine the affected units prior to their return to the sponsor.

Device

Gynecare Thermachoice III Thermal Balloon Ablation Silicone Catheter
  • Modèle / numéro de série
    Gynecare Thermachoice III Thermal Balloon Ablation Silicone CatheterProduct Code: TC033All Lots from 31st November 2013 are affectedARTG Number: 97100
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd

Manufacturer

Johnson & Johnson Medical Pty Ltd