Events

Rappel de Baxter Clearlink Solution Sets

Selon New Zealand Medicines and Medical Devices Safety Authority, ce/cet/cette rappel concerne un dispositif en/au/aux/à New Zealand qui a été fabriqué par Baxter Healthcare Corporation.

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
    15021
  • Date de mise en oeuvre de l'événement
    2013-07-29
  • Pays de l'événement
    New Zealand
  • Source de l'événement
    NZMMDSA
  • URL de la source de l'événement
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alertes
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notes supplémentaires dans les données
    Recalling Organisation: Baxter Healthcare Ltd, 33 Vestey Drive, Mt Wellington, AUCKLAND
  • Cause
    Manufacturer received feedback from a customer that an iv tube could not be loaded into a infusion pump because the side clamp was not correctly assembled. manufacturer confirmed that the complaint sample and confirmed side clamp assembled in the reverse direction. the incorrect assembly would lead to incorrect direction of infusion such that blood may withdrawn froma patient and result in acute blood loss and/ or delay in treatment of life sustaining medication as worst case scenario.
  • Action
    Product to be returned to supplier

Device

Baxter Clearlink Solution Sets
  • Modèle / numéro de série
    Model: FNC3110, Affected: SR13A04021, SR13A02041, SR13A07032, SR13B14077
  • Manufacturer
    Baxter Healthcare Corporation

Manufacturer

Baxter Healthcare Corporation