Events

Rappel de Kii Abdominal Troacar5x55mm Kii Optical Z-Thread Dual Pack

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Applied Medical 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-01102-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-08-23
  • 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-01102-1
  • 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
    Applied medical has been advised that during shipment, the packaging of specific lots of kii abdominal troacars have the potential to become punctured with small holes, which would compromise the sterile barrier.
  • Action
    1. Users are to complete the Customer Recall Notification Confirmation Form supplied with the customer letter to acknowledge the recall and indicate if they are returning or have already used the affected lots. 2. If no product is being returned, indicate this on the supplied Customer Recall Notification Confirmation Form 3. Return the supplied Recall Notification Confirmation Form to Applied Medical Australia 4. Return affected product and a copy of the supplied Recall Notification Confirmation Form to Applied Medical.

Device

Kii Abdominal Troacar5x55mm Kii Optical Z-Thread Dual Pack
  • Modèle / numéro de série
    Kii Abdominal Troacar5x55mm Kii Optical Z-Thread Dual PackModel Number: CTR14Lot Numbers: 1269694, 1275188, 1279039, 1283226, and 1287785ARTG Number: 224148
  • Manufacturer
    Applied Medical Australia Pty Ltd

Manufacturer

Applied Medical Australia Pty Ltd