Events

Rappel de Cook Biodesign 1-Layer Tissue Graft and Cook Biodesign 4-Layer Tissue Graft

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par William A Cook 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-00328-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-04-06
  • 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-00328-1
  • 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
    Cook medical is instigating a change in the intended use wording of the product instructions for use (ifu). this change is in response to the report of two potential adverse events during use in urological or gynecological procedures. this change will provide clarification of the product's intended use, with the addition of the following statement in the ifu: "this device is not intended for use in urological or gynaecological procedures".
  • Action
    Cook is advising users of an update to the intended use in the instructions for use to clarify that the devices are not intended for use in urological or gynaecological procedures. A new version of the instructions for use that includes the updated intended use will be introduced within the next few months. In the interim, each device will be supplied with a leaflet that includes notice of the update.

Device

Cook Biodesign 1-Layer Tissue Graft and Cook Biodesign 4-Layer Tissue Graft
  • Modèle / numéro de série
    Cook Biodesign 1-Layer Tissue Graft and Cook Biodesign 4-Layer Tissue GraftCook Biodesign 1-Layer Tissue Graft Model Numbers: C-SLH-1S-2X3, C-SLH-1S-7X10, SLH-1S-7X10Cook Biodesign 4-Layer Tissue GraftModel Numbers: C-SLH-4S-1X10, C-SLH-4S-2X3, C-SLH-4S-4X7, C-SLH-4S-7X10, C-SLH-4S-7X20, J-SLH-4S-7X20, J-SLH-4S-4X7, J-SLH-4S-7X10, SLH-4S-2X3, SLH-4S-3.5X5, SLH-4S-4X7, SLH-4S-7X10, SLH-4S-7X20ARTG Number: 153047
  • Manufacturer
    William A Cook Australia Pty Ltd

Manufacturer

William A Cook Australia Pty Ltd