Events

Rappel de INTUBATION FIBERSCOPE

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par KARL STORZ SE & CO. KG.

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
    98924
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2013-11-07
  • 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
    It has been determined that these endoscopes incorporate a lumen material that is only approved for use as an external surface material and not included in the sterrad nx and 100nx labeling claims for use in flexible endoscope lumens. this could result in lower than expected levels of hydrogen peroxide within the lumen during the exposure phase of the sterilization cycle and compromise sterilization efficacy.

Device

INTUBATION FIBERSCOPE
  • Modèle / numéro de série
    Model Catalog: 11301AA1 (Lot serial: All numbers affected.); Model Catalog: 11004BC1 (Lot serial: All numbers affected.); Model Catalog: 11301BN1 (Lot serial: All numbers affected.); Model Catalog: 11302BD1 (Lot serial: All numbers affected.); Model Catalog: 11302BD2 (Lot serial: All numbers affected.); Model Catalog: 11302BDD2 (Lot serial: All numbers affected.); Model Catalog: 11009BC1 (Lot serial: All numbers affected.); Model Catalog: 11340BC1 (Lot serial: All numbers affected.); Model Catalog: 11304BC1 (Lot serial: All numbers affected.); Model Catalog: 11302BDD1 (Lot serial: All numbers affected.); Model Catalog: 11301BND1 (Lot serial: All numbers affected.); Model Catalog: 11001BN1 (Lot serial: All numbers affected.); Model Catalog: 11002BD1 (Lot serial: All numbers affected.)
  • Description du dispositif
    B. Flexible Intubation Fiberscopes with Suction Port
  • Manufacturer
    KARL STORZ SE & CO. KG

Manufacturer

KARL STORZ SE & CO. KG