Events

Rappel de Niti-S Biliary Covered Stent (Flare-Type) Nagi/Pseudocyst 10mm x 3cm

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-2013-RN-00615-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2013-06-27
  • 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-2013-RN-00615-1
  • 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
    The manufacturer has identified that there is a potential problem with the loosening of the y connector on the hub of the delivery sheath which is outside the patient's body during delivery of the stent.The outer sheath and y connector should be adjoined each other using glue as well as screw compression, however the gluing process was skipped in some cases with the affected lot number during manufacturing.
  • Action
    Pyramed is asking customers to return the affected stock for replacement with unaffected stock.

Device

Niti-S Biliary Covered Stent (Flare-Type) Nagi/Pseudocyst 10mm x 3cm
  • Modèle / numéro de série
    Niti-S Biliary Covered Stent (Flare-Type) Nagi/Pseudocyst 10mm x 3cm Model number: BS1003FWLot number: 13D1394D3EB780 Expiry date: 2016-04ARTG number: 130531
  • Manufacturer
    Pyramed Pty Ltd

Manufacturer

Pyramed Pty Ltd