Events

Rappel de Stryker NV Excelsior (used to assist in the delivery of diagnostic agents) SL-10 90deg 2-Tip, NV Neuroform 3EZ-3.0x15mm and 3EZ-3.5x15mm Microcatheters (used with occlusive devices in the treatment of intracranial aneurysms)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Stryker 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-2013-RN-01156-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2013-11-11
  • 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-01156-1
  • 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
    Stryker has become aware that certain lots of the affected neurovascular products have incorrect product expiry dates printed on the packaging. all products are currently still within their validated expiry date, the earliest expiry date being april 2015.
  • Action
    Stryker is requesting users inspect stock and return affected stock to Stryker for replacement.

Device

Stryker NV Excelsior (used to assist in the delivery of diagnostic agents) SL-10 90deg 2-Tip, NV ...
  • Modèle / numéro de série
    Stryker NV Excelsior (used to assist in the delivery of diagnostic agents) SL-10 90deg 2-Tip, NV Neuroform 3EZ-3.0x15mm and 3EZ-3.5x15mm Microcatheters (used with occlusive devices in the treatment of intracranial aneurysms) NV Excelsior SL-10 90deg 2-Tip Neurovascular MicrocatheterCatalogue No: 168191Lot No: 17045959ARTG Number: 177031NV Neuroform 3EZ-3.0x15mm, 3EZ-3.5x15mm Stent SystemCatalogue Nos: EN3E3015, EN3E3515Lot Nos: 17032024, 17032027ARTG Number: 172281
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

Stryker Australia Pty Ltd
  • Société-mère du fabricant (2017)
    Stryker
  • Source
    DHTGA