Events

Rappel de KIMVENT NEONATAL / PEDIATRIC "Y" TRACHEAL SUCTION SYSTEM

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par CANADIAN HOSPITAL SPECIALTIES 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
    77945
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2015-08-12
  • 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
    Halyard health has recently received reports indicating that the thumb valve of a very small percentage of kimvent closed suction systems remained partially open after suctioning was completed even though the valve appeared to be closed or in the "locked" position.

Device

KIMVENT NEONATAL / PEDIATRIC "Y" TRACHEAL SUCTION SYSTEM
  • Modèle / numéro de série
    Model Catalog: 196 (Lot serial: M5110T505); Model Catalog: 1910 (Lot serial: M5110T505); Model Catalog: 198-5 (Lot serial: M5082T513); Model Catalog: 196 (Lot serial: M5082T513); Model Catalog: 1910 (Lot serial: M5082T513); Model Catalog: 198-5 (Lot serial: M5082T502); Model Catalog: 196 (Lot serial: M5082T502); Model Catalog: 1910 (Lot serial: M5082T502); Model Catalog: 198-5 (Lot serial: M5110T505); Model Catalog: 2260-5 (Lot serial: M5124T606); Model Catalog: 22109-5 (Lot serial: M5124T606); Model Catalog: 22103-5 (Lot serial: M5124T606); Model Catalog: 2260-5 (Lot serial: M5082T614); Model Catalog: 22103-5 (Lot serial: M5085T604); Model Catalog: 22103-5 (Lot serial: M5082T614); Model Catalog: 2260-5 (Lot serial: M5085T604); Model Catalog: 22109-5 (Lot serial: M5085T604); Model Catalog: 22109-5 (Lot serial: M5082T614)
  • Description du dispositif
    KIMVENT NEONATAL / PEDIATRIC "Y" TRACHEAL SUCTION
  • Manufacturer
    CANADIAN HOSPITAL SPECIALTIES LTD.

Manufacturer

CANADIAN HOSPITAL SPECIALTIES LTD.