Events

Rappel de FemoSeal

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 St Jude Medical 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
    21834
  • Date de mise en oeuvre de l'événement
    2017-08-21
  • 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: Terumo Australia Pty Ltd (NZ), c/- Healthcare Logistics, 56 Carrington Road, Mount Albert, Auckland 1025
  • Cause
    The manufacturers investigation has identified that the internal suture becomes entrapped as a result of operator misassembly during device manufacture and that this issue then only becoming visible midway through device deployment. internal controls have been established in manufacturing to eliminate the potential for this defect to recur.
  • Action
    Product to be returned to supplier

Device

FemoSeal
  • Modèle / numéro de série
    Model: , Affected: All non-expired product Manufactured August 2016 - July 2017
  • Manufacturer
    St Jude Medical Inc

Manufacturer

St Jude Medical Inc