Events

Rappel de QUIK-COMBO REDI-PAK PACING/DEFIBRILLATION/ECG ELECTRODE

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par PHYSIO-CONTROL CANADA SALES 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
    120764
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2016-02-04
  • 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
    Physio-control's supplier of quik-combo adult pacing/defibrillation/ecg electrodes with edge system technology and redi-pak preconnect system is voluntarily recalling specific production lots. the defibrillation electrodes are used in conjunction with certain physio-control lifepak products. this voluntary recall is being conducted due to a low-level potential for damage to the wire insulation during the manufacturing process of the affected lots. the use of products with this condition may result in a potentially increased risk for reduced or no patient therapy arcing of current sparking and patient and/or clinician burns.

Device

QUIK-COMBO REDI-PAK PACING/DEFIBRILLATION/ECG ELECTRODE
  • Modèle / numéro de série
    Model Catalog: 3202674-XXX (Lot serial: 516907); Model Catalog: 3202674-XXX (Lot serial: 519815); Model Catalog: 3202674-XXX (Lot serial: 519816)
  • Description du dispositif
    PHYSIO-CONTROL QUIK-COMBO PACING/DEFIBRILLATION/ECG ELECTRODES WITH EDGE SYSTEM TECHNOLOGY AND REDI-PAK PRECONNECT SYSTEM;Quik-Combo pacing/defibrillation/ECG electordes with EDGE System technology and REDI-PAK preconnect system
  • Manufacturer
    PHYSIO-CONTROL CANADA SALES LTD

Manufacturer

PHYSIO-CONTROL CANADA SALES LTD
  • Adresse du fabricant
    HAMILTON
  • Société-mère du fabricant (2017)
    Stryker
  • Source
    HC