Events

Rappel de 10mm Direct Drive Clip Applier (Used for ligation of tubular structures or vessels in laparoscopic and general surgical procedures)

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-2016-RN-00387-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-04-05
  • 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-2016-RN-00387-1
  • 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
    Due to inconsistent clip application, the 10mm direct drive clip applier is being recalled. although malformed clips are typically readily apparent to the user, this failure mode may lead to unoccluded vessels.
  • Action
    Applied Medical is advising users to check inventory for the affected lots and return any affected product. This action has been closed-out on 30/01/2017.

Device

10mm Direct Drive Clip Applier (Used for ligation of tubular structures or vessels in laparoscopi...
  • Modèle / numéro de série
    10mm Direct Drive Clip Applier (Used for ligation of tubular structures or vessels in laparoscopic and general surgical procedures)Product Code: CA090Affected Lot Numbers: 1190181 to 1265006Expiry date: Prior to 18 March 2019Affected Kit Product Codes: CK304, GK306, GK307, GK311, GK312, GK317, GK318, GK323, GK334, GK335, K0509 and K0592ARTG Number: 221008
  • Manufacturer
    Applied Medical Australia Pty Ltd

Manufacturer

Applied Medical Australia Pty Ltd