Events

Rappel de ARCTICGEL PADS

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par BARD 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
    54934
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2017-11-07
  • 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
    Bard has received complaints reporting that the hydrogel peeled away from pads during the removal of the release liner. the issue affects specific lots of arcticgel pad kits and may result in the insufficient adhesion of the hydrogel to the pad. product return is not required as part of this recall notification.

Device

ARCTICGEL PADS
  • Modèle / numéro de série
    Model Catalog: 317-03 (Lot serial: NGBN3536); Model Catalog: 317-00 (Lot serial: NGAW3055); Model Catalog: 317-05 (Lot serial: NGBN3536); Model Catalog: 317-00 (Lot serial: NGBN3536); Model Catalog: 317-03 (Lot serial: NGAZ2312); Model Catalog: 317-07 (Lot serial: NGAZ2312); Model Catalog: 317-05 (Lot serial: NGAZ2312); Model Catalog: 317-00 (Lot serial: NGAZ2312); Model Catalog: 317-03 (Lot serial: NGAW4510); Model Catalog: 317-07 (Lot serial: NGAW4510); Model Catalog: 317-05 (Lot serial: NGAW4510); Model Catalog: 317-00 (Lot serial: NGAW4510); Model Catalog: 317-03 (Lot serial: NGBQ2024); Model Catalog: 317-07 (Lot serial: NGBQ2024); Model Catalog: 317-05 (Lot serial: NGBQ2024); Model Catalog: 317-00 (Lot serial: NGBQ2024); Model Catalog: 317-03 (Lot serial: NGBQ1040); Model Catalog: 317-07 (Lot serial: NGBQ1040); Model Catalog: 317-05 (Lot serial: NGBQ1040); Model Catalog: 317-00 (Lot serial: NGBQ1040); Model Catalog: 317-03 (Lot serial: NGBP1302); Model Catalog: 317-07 (Lot serial: NGBP1302); Model Catal
  • Description du dispositif
    ARCTICGEL PADS (FOR ARCTIC SUN 5000 MODEL);ARCTICGEL PADS (FOR ARCTIC SUN 2000 MODEL)
  • Manufacturer
    BARD CANADA INC.

Manufacturer

BARD CANADA INC.