Events

Rappel de VenoCath Drum Cartridge Catheter (intravascular 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 Hospira Pty Limited.

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-2012-RN-00959-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2012-09-25
  • 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-2012-RN-00959-1
  • 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.
    ICU Medical, Inc. acquired from Pfizer in early 2017, Hospira Infusion Systems, the portion of Hospira dedicated to develop infusion pumps.
  • Notes supplémentaires dans les données
  • Cause
    Hospira has received reports from customers of drum cartridge catheter reports of the drum catheter dismantling/uncoiling before or during use/insertion. there have been complaints related to difficulty in inserting the catheter, leaks and separations, breakage of the catheter inside patient during insertion.
  • Action
    Hospira is asking customers to immediately quarantine and return the affected stock for credit. Hospira is not going to continue to supply this product and is suggesting customer identify alternative products.

Device

VenoCath Drum Cartridge Catheter (intravascular catheter)
  • Modèle / numéro de série
    VenoCath Drum Cartridge Catheter (intravascular catheter)List Number: 100G8920610H1ARTG Number: 161905
  • Manufacturer
    Hospira Pty Limited

Manufacturer

Hospira Pty Limited
  • Société-mère du fabricant (2017)
    Pfizer
  • Source
    DHTGA