Events

Rappel de GemStar Docking Station (Used as an alternate power source for the GemStar pump and to charge a GemStar battery pack)

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-00708-3
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2012-07-26
  • 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-00708-3
  • 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
    This is an update to hospira’s previous safety alert notice (tga ref # rc-2011-rn-00812-3) concerning the gemstar docking station. at that time, hospira had received reports from customers of sparking, smoking, charring and electrical shock when using the gemstar docking station. hospira’s investigation concluded that the primary root cause was related to the potential for fluid ingress into the docking station. the design improvements have now been finalised and hospira is replacing all existing docking stations with the new design.
  • Action
    Customers to advise Sponsor of the number of docking stations held and they will be replaced with the newly designed units.

Device

GemStar Docking Station (Used as an alternate power source for the GemStar pump and to charge a G...
  • Modèle / numéro de série
    GemStar Docking Station (Used as an alternate power source for the GemStar pump and to charge a GemStar battery pack)List Numbers: 13075.1 and 13075.3 (2003 - 2006); 13075-24-03, 13075-24-05 & 13075-24-07 (2006 - 2011)ARTG Number: 138118
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Manufacturer
    Hospira Pty Limited

Manufacturer

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