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.
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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.