Events

Rappel de Bard 100% Latex-Free Urinary Drainage Bag with Anti-Reflux Chamber and Bard EZ-Lok

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Bard 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-01095-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-11-09
  • 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-01095-1
  • 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
    Bard has identified that some devices from a specific lot of product have a potential breach of the sterile barrier packaging. this defect may put patients at an increased risk of an ascending urinary tract infection. symptoms of an infection could include fever, pain and burning sensation upon voiding.
  • Action
    Bard is requesting users inspect their stocks and to quarantine affected units prior to return as per the instructions in the customer letter. If customers have used any affected product, monitor the relevant patients for symptoms and signs of localised and/or systemic infection. This action has been closed-out on 22/08/2016.

Device

Bard 100% Latex-Free Urinary Drainage Bag with Anti-Reflux Chamber and Bard EZ-Lok
  • Modèle / numéro de série
    Bard 100% Latex-Free Urinary Drainage Bag with Anti-Reflux Chamber and Bard EZ-Lok Catalogue Number: 154006Lot Number: NGYJ0603ARTG Number: 195134
  • Manufacturer
    Bard Australia Pty Ltd

Manufacturer

Bard Australia Pty Ltd