Events

Rappel de WECK Visistat 35R Disposable Skin Stapler

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Teleflex 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-00508-1
  • Classe de risque de l'événement
    Class III
  • Date de mise en oeuvre de l'événement
    2017-04-20
  • 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-00508-1
  • 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
    For a single product lot, teleflex medical has identified a labelling error on the boxes which contain six individually packaged and labelled device units. some boxes are labelled as containing visistat wide devices, when they in fact contain visistat regular devices. the individual units are correctly labelled with the actual size of the device. the labelling error applies only to some units of sales boxes in the affected lot number. it is unlikely that the use of these products will result in any adverse health consequences, although it is possible there could be a delay of the procedure.
  • Action
    Teleflex is advising users of the labelling error, and requesting that they place a copy of the customer letter detailing the issue with the affected lot.

Device

WECK Visistat 35R Disposable Skin Stapler
  • Modèle / numéro de série
    WECK Visistat 35R Disposable Skin StaplerProduct Code: 528135Lot Number: 73H1600207ARTG Number: 126367
  • Manufacturer
    Teleflex Medical Australia Pty Ltd

Manufacturer

Teleflex Medical Australia Pty Ltd