Events

Rappel de CareFusion Alaris SmartSite Needlefee connector

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 CareFusion Switzerland 317 Sarl.

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
    16318
  • Date de mise en oeuvre de l'événement
    2014-02-27
  • 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: CareFusion New Zealand 313 Limited, Unit 14, 13 Highbrook Drive, East Tamaki, AUCKLAND
  • Cause
    Carefusion has identified potential risks with model code 2000e and batch numbers noted below due to possible connection issues. the affected smartsite connector batches may unintentionally disconnect from a female luer, or may be difficult to disconnect from a female luer, or may fail to disconnect from a female luer once attached. an inability to disconnect may require replacement of a line. leakage may also be observed if the connector disconnects from the female luer during infusion.
  • Action
    Product to be returned to supplier

Device

CareFusion Alaris SmartSite Needlefee connector
  • Modèle / numéro de série
    Model: Model: 2000e, Affected: Lots: 13086446, 13095944, 13095778, 13106753, 13106848, 13096013, 13095675, 13106018
  • Manufacturer
    CareFusion Switzerland 317 Sarl

Manufacturer

CareFusion Switzerland 317 Sarl