Events

Rappel de Groshong NXT PICC Connector (used to repair the damaged external segment of a 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-2016-RN-00555-1
  • Classe de risque de l'événement
    Class III
  • Date de mise en oeuvre de l'événement
    2016-04-28
  • 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-2016-RN-00555-1
  • 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 access systems has received reports involving an incorrect connector colour indicated on the product labelling for specific lots of the replacement connector for groshong nxt picc (for use with groshong nxt, 5 fr. dual-lumen picc). the case label for the specific lot incorrectly identified the connector colour as “white”. the connector is red and is correctly identified by the unit label as “red”.
  • Action
    Bard is advising users to be aware of the issue. The affected product remains safe to use and there is no requirement to return the affected product. This action has been closed-out on 25/01/2017.

Device

Groshong NXT PICC Connector (used to repair the damaged external segment of a catheter)
  • Modèle / numéro de série
    Groshong NXT PICC Connector (used to repair the damaged external segment of a catheter) Product Code: 7812500 Lot Number: REVH0705ARTG Number: 136492
  • Manufacturer
    Bard Australia Pty Ltd

Manufacturer

Bard Australia Pty Ltd