Events

Rappel de Abbott Hi-Torque Connect Peripheral 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 Lake Region Medical 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
    15736
  • Date de mise en oeuvre de l'événement
    2013-11-27
  • 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: Abbott Vascular Division of Abbott Laboratories (NZ) Ltd, Ground Floor, Building D, 4 Pacific Rise, Mount Wellington, Auckland 1060
  • Cause
    Abbott vascular has initiated this recall due to a small number of devices exhibiting partial delamination of the ptfe coating. to date, the frequency of worldwide reported incidents of delamination of the coating is 0.08%. while there have been no long term or irreversible patient effects reported, potential risks associated with delamination of the coating include embolism, thrombus and occlusion in the peripheral vessels.
  • Action
    Product to be returned to supplier

Device

Abbott Hi-Torque Connect Peripheral Guide Wire
  • Modèle / numéro de série
    Model: Part Numbers: 1012587, 1012588, 1012589, 1012590, 1012591, 1012592, 1012593, 1012594, 1012595, Affected: All lot numbers
  • Manufacturer
    Lake Region Medical Ltd

Manufacturer

Lake Region Medical Ltd