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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This recall is being initiated by bard canada in order to inform users of a safety concern while using temperature simulator keys with the arctic sun temperature management system. two adverse events have been reported to bard medical division. in each instance a temperature simulator key (product code 748-00 and as part of service kit 771-00) was connected to the patient temperature cable instead of the patient temperature probe. due to the false patient temperature reading from the temperature simulator key improper targeted temperature therapy was delivered to the patients.