Events

Rappel de AngioDynamics Morpheus Smart PICC CT (Central venous catheters)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Medical Specialties 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-2015-RN-00263-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-03-23
  • 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-00263-1
  • 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
    Angiodynamics, the manufacturer of morpheus smart picc ct kits is conducting a medical device recall on specific kit / lot numbers of power injectable picc catheters. based on a review of complaints, angiodynamics has determined that the power injectable picc catheters contained in these kits exhibit a higher than anticipated rate of extension tube fracture or leakage. use of the picc catheters that are subject to this recall may have an increased incidence of extension tube fractures or leakage which would require replacement of the picc catheter.
  • Action
    Customers are advised to segregate affected stock to a secure location for return to the Medical Specialties Australia. This action has been closed-out on 1/06/2016.

Device

AngioDynamics Morpheus Smart PICC CT (Central venous catheters)
  • Modèle / numéro de série
    AngioDynamics Morpheus Smart PICC CT (Central venous catheters)Catalogue number:12102602 Lot number: 583841 Catalogue number: 12102605Lot number: 588129Catalogue number:12102802Lot number: 601006 Catalogue number:12102813Lot number: 603510ARTG number: 204787
  • Manufacturer
    Medical Specialties Australia Pty Ltd

Manufacturer

Medical Specialties Australia Pty Ltd
  • Source
    DHTGA