Events

Rappel de Cook Inc Catheter, Angiography

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 Group Inc.

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
    19954
  • Date de mise en oeuvre de l'événement
    2016-04-27
  • 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: Obex Medical Ltd, 303 Manukau Road, Epsom, AUCKLAND
  • Cause
    Manufacturer is initiating a recall of listed products as they have identified an increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/ or separation., preliminary investigation into this matter has identified that environmental conditions such as storage temperature, humidity and the use of vapourised hydrogen peroxide for whole-room decontamination within healthcare facilities, may be contributing to this occurrence., potential adverse events that may occur as a result if catheter polymer degradation coudl include loss of device function, separation of a device segment leading to medical intervention, or complications resulting from a separated segment. (eg; device fragments in the vascular system, genitourinary system or other soft tissues).
  • Action
    Product to be returned to supplier

Device

Cook Inc Catheter, Angiography
  • Modèle / numéro de série
    Model: , Affected: all lots
  • Manufacturer
    Cook Group Inc

Manufacturer

Cook Group Inc