Events

Rappel de Clearlink System Solution Set (Infusion administration set)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Baxter Healthcare 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-2013-RN-00741-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2013-07-19
  • 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-2013-RN-00741-1
  • 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
    Baxter anz received feedback from a customer that an iv tube could not be loaded into an infusion pump because the slide clamp was not correctly assembled. baxter facility received the complaint sample and confirmed the slide clamp had been assembled in the reverse direction. the incorrect assembly would lead to incorrect direction of infusion such that blood may be withdrawn from a patient and result in acute blood loss and/or delay in treatment of life sustaining medication as a worse case scenario.
  • Action
    Baxter Healthcare are advising customers to remove affected product from use and return to Baxter for credit.

Device

Clearlink System Solution Set (Infusion administration set)
  • Modèle / numéro de série
    Clearlink System Solution Set (Infusion administration set)Product Code: FNC3110Lot Numbers: SR13A04021, SR13A02041, SR13A07032 (Expiration date: Jan 2018), SR13B14077 (Expiration date: Feb 2018)
  • Manufacturer
    Baxter Healthcare Pty Ltd

Manufacturer

Baxter Healthcare Pty Ltd