Events

Recall of ARCTICGEL PADS

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by BARD CANADA INC..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    54934
  • Event Risk Class
    II
  • Event Initiated Date
    2017-11-07
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    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
  • Model / Serial
    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
  • Product Description
    ARCTICGEL PADS (FOR ARCTIC SUN 5000 MODEL);ARCTICGEL PADS (FOR ARCTIC SUN 2000 MODEL)
  • Manufacturer
    BARD CANADA INC.

Manufacturer

BARD CANADA INC.