Events

Rappel de STRYKER 40L HIGH FLOW INSUFFLATOR - TUBING

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

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
    144348
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2010-03-23
  • 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
    Stryker endoscopy has become aware that the stryker heated insufflators may have been received with no expiration date printed on the label. additionally it was discovered that no packaging shelf-life testing had been completed for those products during the initial product launch. stryker has also become aware that the above referenced products may have been released for distribution and sold in countries that may have regulations regarding label expiration.

Device

STRYKER 40L HIGH FLOW INSUFFLATOR - TUBING
  • Modèle / numéro de série
    Model Catalog: 0620-030-407 (Lot serial: >100 NUMBERSCONTACT MFG)
  • Description du dispositif
    STRYKER HEATED INSUFFLATORS
  • Manufacturer
    STRYKER CANADA LP

Manufacturer

STRYKER CANADA LP
  • Adresse du fabricant
    HAMILTON
  • Société-mère du fabricant (2017)
    Stryker
  • Source
    HC