Events

Rappel de Lifemed Urinary Drainage Bag with Pump

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-2014-RN-01058-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-10-03
  • 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-2014-RN-01058-1
  • 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 australia has received nine (9) reports of the bard australia lifemed urinary drainage bag being incorrectly assembled with the bulb located in the wrong position. incorrect positioning of the bulb in relation to the inlet tube makes it more difficult to use to the product for its intended purpose. no reports of injuries or harm to the patient or user have been reported.
  • Action
    Customers are advised to check all inventory locations within their institution for the affected stock and segregate these items from their inventory for returning to Bard Australia. This action has been closed-out on 01/03/2016.

Device

Lifemed Urinary Drainage Bag with Pump
  • Modèle / numéro de série
    Lifemed Urinary Drainage Bag with PumpProduct Code: L153514Lot Number: NGXL1240ARTG Number: 163481
  • Manufacturer
    Bard Australia Pty Ltd

Manufacturer

Bard Australia Pty Ltd