Events

Rappel de NON-STERILE STEP DOWN CONNECTOR

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par INTEGRA CANADA ULC..

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
    121020
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2011-12-05
  • Pays de l'événement
    Canada
  • Source de l'événement
    HC
  • Notes / Alertes
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notes supplémentaires dans les données
  • Cause
    Integra lifesciences corporation (integra) has recently become aware that the current packaging configuration for the non-sterile step down connector may lead to a potentially conflicting message regarding product sterility. this individually sold non-sterile stepdown connector is packaged with a label that correctly states the product is non-sterile and also with instructions for use (ifu) from the sterile kit with which it is designed to be used as a reference to the customers. although the accessories are marked on the external label as non-sterile the ifu which is visible through the packaging states that the related shunt kit is sterile. this may lead to confusion as to whether these non-sterile products are sterile.

Device

NON-STERILE STEP DOWN CONNECTOR
  • Modèle / numéro de série
    Model Catalog: NL8600401 (Lot serial: )
  • Description du dispositif
    NON-STERILE STEP DOWN CONNECTOR
  • Manufacturer
    INTEGRA CANADA ULC.

Manufacturer

INTEGRA CANADA ULC.