Events

Rappel de CIRCON CABOT FALOPE-RING BAND TUBAL OCCLUSION SYSTEM

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par OLYMPUS CANADA 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
    32993
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2014-06-30
  • 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
    On april 4 2014 a communication from the osta us distributor drew attention to the fact that part 000878-4 falope-ring dilator was inadvertently made available through the order system to customers and osta was shipping this item to our distributors in a non-sterile state. this item is normally only intended for use as a component provided with the falope ring band frb- 30 kits. the frb-30 kits including this component are sold sterile. this item is a dilator intended to assist placement of the falope band on the applicator. it contacts the sterile falope ring band as the band is loaded onto a reusable applicator and just prior to the band's implantation in the patient. as such it must be sterile in order to avoid the possibility of contaminating the falope ring band prior to use. no complaints related to these items have been received.

Device

CIRCON CABOT FALOPE-RING BAND TUBAL OCCLUSION SYSTEM
  • Modèle / numéro de série
    Model Catalog: 000878-4 (Lot serial: N/A)
  • Description du dispositif
    GYRUS ACMI FALOPE-RING DILATOR
  • Manufacturer
    OLYMPUS CANADA INC.

Manufacturer

OLYMPUS CANADA INC.