Events

Rappel de Nv Guider Catheter 90cm NV GUIDER CATHETER 90CM 40° 7F; NV GUIDER CATHETER 90CM ST 7F; NV GUIDER CATHETER 90CM ST 8F

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-2017-RN-01517-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-12-18
  • 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-01517-1
  • 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 initiated a lot specific product recall on certain lots of guider 7f and 8f product which may be at risk of degrading within their shelf-life period. the root cause of the issue is exposure of components to uv light while in storage between 2014 and october 2017.There have been no reports of injuries associated with this issue.
  • Action
    Stryker is advising users to inspect stock an quarantine any remaining units of the affected product. Affected stock can be returned to Stryker and replaced with unaffected product.

Device

Nv Guider Catheter 90cm NV GUIDER CATHETER 90CM 40° 7F; NV GUIDER CATHETER 90CM ST 7F; NV GUIDER ...
  • Modèle / numéro de série
    Nv Guider Catheter 90cm NV GUIDER CATHETER 90CM 40° 7FItem Number: 10043 Lot Numbers: 19948645, 18836128, 19545073, 19793264, 19809517, 20024281 NV GUIDER CATHETER 90CM ST 7FItem Number: 10051 Lot Numbers: 18898135, 18898416NV GUIDER CATHETER 90CM ST 8F Item Number: 10052 Lot Numbers: 18643117ARTG Number: 146034
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

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