Events

Rappel de Vascutek Thoraflex Hybrid Device

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 Vascutek 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
    17011
  • Date de mise en oeuvre de l'événement
    2014-07-16
  • 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: Obex Medical Ltd, 303 Manukau Road, Epsom, AUCKLAND
  • Cause
    Manufacturer provides a high temperature cautery with each gelweave and thoraflex hybrid product and a low temperature cautery with each biovalsalva stentless biplex , stented biovalsalva biplex and rvot elan biplex conduit. these cauteries are used to cut and trim the graft. manufacturer has decided to stop supplying the cautery with these product packs due to the cautery battery having a shorter shelf life than the vascutek graft product. manufacturer will update the ifu, removing the reference to the inclusion of a catery with thes products., manufacturer will not be recalling any product as there is negligible rsk to users and patients.
  • Action
    Instructions for use to be updated

Device

Vascutek Thoraflex Hybrid Device
  • Modèle / numéro de série
    Model: , Affected: all lots
  • Manufacturer
    Vascutek Ltd

Manufacturer

Vascutek Ltd