Events

Rappel de Cook Inc - Guide Wire

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 Cook Incorporated.

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
    22185
  • Date de mise en oeuvre de l'événement
    2017-11-03
  • 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
    The manufacturer has identified that the label of heparin coated devices does not explicitly state that they are heparin coated. the products are labeled with the correct catalog identifier, which includes the suffix bh that indicates the product is heparin coated. however, users who are not familiar with the bh nomenclature may not be aware that the product contains heparin.
  • Action
    Manufacturer to issue advice regarding use

Device

Cook Inc - Guide Wire
  • Modèle / numéro de série
    Model: , Affected: Vascular guides and catheters multiple lots
  • Manufacturer
    Cook Incorporated

Manufacturer

Cook Incorporated