Events

Rappel de Cook LapSac Surgical Tissue Pouch

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-2015-RN-00500-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-06-19
  • 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-2015-RN-00500-1
  • 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
    Updates to the ifu are being made to discourage use of laparoscopic power morcellation in cases where the presence of cancerous tissue cannot be ruled out. the intended use for the device is being modified from "used to isolate tissue during, or prior to, surgical removal and or morcellation" to "used to isolate tissue during, or prior to surgical removal". a contraindication i.E., 'not for use with power morcellators' is also being added to the ifu. additionally, warnings and instructions in the ifu is being updated.
  • Action
    Customers are advised to pass the customer letter on to appropriate personnel within their organisation or to any organisation where the potentially affected devices have been transferred. This action has been closed-out on 26/08/2016.

Device

Cook LapSac Surgical Tissue Pouch

Manufacturer

William A Cook Australia Pty Ltd