Rappel de GUIDELINER Intravascular Guiding 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 Pyramed 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-2012-RN-00779-3
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2012-08-22
  • Pays de l'événement
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
  • 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
    Guideliner catheter is being recalled due to a regulatory compliance issue. guideliner catheter has now been cancelled from the australian register of therapeutic goods (artg) because it should have been classified as a class iii medical device, not a class iia medical device in accordance with the therapeutic goods (medical devices) regulations 2002. the guideliner catheter has not undergone the more rigorous pre-market conformity assessment procedure relevant to a class iii device to provide assurance of its quality, safety and performance. in particular, the tga has not been provided with appropriate data on the design verification and validation of the device necessary for a class iii classification.
  • Action
    Pyramed is asking customers to identify and quarantine the Guideliner Catheter stock and advising that it cannot be used other than in accordance with the specific conditions attached to the Special Access Scheme (SAS).

Device

  • Modèle / numéro de série
    GUIDELINER Intravascular Guiding Catheter Previous ARTG: 180817All remaining stock in the market
  • Manufacturer

Manufacturer