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 is informing customers that use of the arctic sun temperature management system in excess of 2000 system hours without conducting preventative maintenance may result in failure of certain components of the system particularly in relation to the mixing pump which runs continuously during operation. failure of the mixing pump may cause the device to cease to function as intended resulting in no availability of cooling or rewarming therapy for the patient.