Events

Rappel de Ethicon HARMONIC ACE+ 7 Laparoscopic Shears

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Johnson & Johnson Medical 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-00994-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-10-08
  • 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-00994-1
  • 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
    The manufacturer has determined that under extreme handling circumstances, damage, such as a hole, can occur in the tyvek lid due to an interaction between the advanced haemostasis button and tyvek, which would could compromise device sterility. the manufacturer has received no reports of adverse events for this issue.
  • Action
    Johnson & Johnson Medical are advising users of alternative products to use. Users are advised to inspect stock and quarantine any affected product to be returned to Johnson & Johnson. This action has been closed-out on 05/12/2016.

Device

Ethicon HARMONIC ACE+ 7 Laparoscopic Shears
  • Modèle / numéro de série
    Ethicon HARMONIC ACE+ 7 Laparoscopic Shears Product Codes: HARH23, HARH231, HARH36, HARH361, HARH45 and HARH451Batches with expiration dates before 08-2020ARTG Number: 118011
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd

Manufacturer

Johnson & Johnson Medical Pty Ltd