Events

Rappel de Cook Lunderquist Wire Guide

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 William Cook Europe ApS.

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
    18738
  • Date de mise en oeuvre de l'événement
    2015-07-07
  • 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
    Cook medical has received 3 reports of products with the product label indicating the wire guide is curved (the letter "c" in the prefix tscmg- stands for curved), however actual product inside package is a straight wire guide., this observation was made prior to use of the product as the physician is able to see the wire is not curved. the instructions for use (ifu) state "upon removal from package, inspect the product to ensure no damage has occurred.".
  • Action
    Product to be returned to supplier

Device

Cook Lunderquist Wire Guide

Manufacturer

William Cook Europe ApS