Events

Rappel de CIAGLIA BLUE DOLPHIN BALLOON PERCUTANEOUS TRACHEOSTOMY INTRODUCER

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par COOK (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
    24001
  • Classe de risque de l'événement
    I
  • Date de mise en oeuvre de l'événement
    2010-05-03
  • 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
    Certain cuffed shiley tracheostomy tubes in which the cuff does not hold air as a result of leaks in the pilot balloon inflation assembly.

Device

CIAGLIA BLUE DOLPHIN BALLOON PERCUTANEOUS TRACHEOSTOMY INTRODUCER
  • Modèle / numéro de série
    Model Catalog: C-PTBS-2800-PERC8 (Lot serial: G36118); Model Catalog: C-PTBS-2600-PERC6 (Lot serial: G36118); Model Catalog: C-PTBSY-2800-PERC8 (Lot serial: G36116); Model Catalog: C-PTBSY-2600-PERC6 (Lot serial: G36116); Model Catalog: C-PTBS-2800-PERC8 (Lot serial: G36116); Model Catalog: C-PTBS-2600-PERC6 (Lot serial: G36116); Model Catalog: C-PTIS-100-HC-PERC8-CA (Lot serial: G13166); Model Catalog: C-PTIS-100-HC-PERC8 (Lot serial: G13166); Model Catalog: C-PTIS-100-HC-PERC6-CA (Lot serial: G13166); Model Catalog: C-PTIS-100-HC-PERC6 (Lot serial: G13166); Model Catalog: C-PTIS-100-HC-PERC8-CA (Lot serial: G36037); Model Catalog: C-PTIS-100-HC-PERC8 (Lot serial: G36037); Model Catalog: C-PTIS-100-HC-PERC6-CA (Lot serial: G36037); Model Catalog: C-PTIS-100-HC-PERC6 (Lot serial: G36037); Model Catalog: C-PTIS-100-HC-PERC8-CA (Lot serial: G13165); Model Catalog: C-PTIS-100-HC-PERC8 (Lot serial: G13165); Model Catalog: C-PTIS-100-HC-PERC6-CA (Lot serial: G13165); Model Catalog: C-PTIS-100-HC-PERC6 (Lot serial
  • Classification du dispositif
    Anesthesiology Devices
  • Description du dispositif
    ciaglia blue dolphin balloon percutan.
  • Manufacturer
    COOK (CANADA) INC.

Manufacturer

COOK (CANADA) INC.