Events

Rappel de LUTONIX 014 and 035 OTW Drug Coated PTA Dilatation Catheter

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-00153-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2014-02-11
  • 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-00153-1
  • 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
    Lutonix has confirmed that some devices from specific lots may have been packaged in foil pouches with a defective chevron seal. this is the seal used to open the package containing the sterile balloon catheter. the potential hazard associated with a package having a defective chevron seal is loss of sterility.
  • Action
    Customers are asked to not use or further distribute any of the affected product. Bard is advising that no special follow-up treatment or clinical care is recommended for patients who have already undergone treatment with the devices affected by this recall.

Device

LUTONIX 014 and 035 OTW Drug Coated PTA Dilatation Catheter
  • Modèle / numéro de série
    LUTONIX 014 and 035 OTW Drug Coated PTA Dilatation CatheterProduct Codes: 9020413500150 and 9020515250040Lot Numbers: GFXJ2800 and GFXK2769Supplied under the Special Access Scheme
  • Manufacturer
    Bard Australia Pty Ltd

Manufacturer

Bard Australia Pty Ltd