Events

Rappel de COMBINED OXYGEN AND TEMPERATURE PROBE

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

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
    52531
  • Classe de risque de l'événement
    III
  • Date de mise en oeuvre de l'événement
    2014-12-31
  • 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
    Integra lifesciences initiated a recall to remove all affected licox probes and probe kits that may contain an inaccurate smart cards supplied with the subject devices. the ikn2 value in approximately 90% of the potentially affected cards is approximately 10 times higher than it should be resulting in varying degrees of understated po2 values (from -1 mmhg to -7 mmhg) when the probes are used.

Device

COMBINED OXYGEN AND TEMPERATURE PROBE
  • Modèle / numéro de série
    Model Catalog: CC1.P1 (Lot serial: ALL LOT #'S SINCE OCT 1 2013); Model Catalog: CC1.SB (Lot serial: ALL LOT #'S SINCE OCT 1 2013); Model Catalog: IP1.P (Lot serial: ALL LOT #'S SINCE OCT 1 2013); Model Catalog: IP2.P (Lot serial: ALL LOT #'S SINCE OCT 1 2013); Model Catalog: IM3.ST (Lot serial: ALL LOT #'S SINCE OCT 1 2013); Model Catalog: IM1.S (Lot serial: ALL LOT #'S SINCE OCT 1 2013); Model Catalog: IM3.S (Lot serial: ALL LOT #'S SINCE OCT 1 2013); Model Catalog: IT2 (Lot serial: ALL LOT #'S SINCE OCT 1 2013)
  • Description du dispositif
    COMBINED OXYGEN AND TEMPERATURE PROBE
  • Manufacturer
    INTEGRA CANADA ULC.

Manufacturer

INTEGRA CANADA ULC.