Events

Rappel de ProTrack Microcatheter

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Pacing Importers 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-2017-RN-01417-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-11-15
  • 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-2017-RN-01417-1
  • 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
    There is a chance that the affected catheters may have circumferential cracks along its length.If the cracks are present on the device, they are likely to be detected by a physician upon removal of the catheter from the packaging. the cracks may result in leakage of fluids along the catheter. there have been no adverse event reports related to this discovery.
  • Action
    Baylis Medical is advising users to inspect stock and quarantine any unused units for return.

Device

ProTrack Microcatheter
  • Modèle / numéro de série
    ProTrack MicrocatheterPart number: CIC35-145Lot Numbers: CIFA131113, CIFA100614, CIFA100714, CIFA241014Part number: CIC38-145Lot Numbers: CIFA161013, CIFA240614, CIFA.271113, CIFA100714, CIFA311213, CIFA180814, CIFA210214, CIFA080914, CIFA070314, CIFA.221014, CIFA270314, CIFA050115, CIFA070514, CIFA210115, CIFA210514, CIFA060215ARTG Number: 185946
  • Manufacturer
    Pacing Importers Pty Ltd

Manufacturer

Pacing Importers Pty Ltd
  • Source
    DHTGA