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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Sorin has become aware of an increased trend in reports of "fault in motor controller (433)" alarm message events with certain mast roller pumps (mrp) 85 (product code 10-88-60) manufactured between october 6 2011 and august 20 2013. the failure occurs following an intended pump stop. the mrp stops and provides a visual and audible alarm on the system panel. the alarm can be cleared by pressing the reset button and the pump restarted by turning the setting knob. all complaints are related to specific hme motor control circuit boards (product code 90-305-700).