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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The purpose of this correction is to upgrade the neptune 2 waste management system to the new approved specifications. previously stryker had received reports that the neptune 2 had been connected directly to a chest tube postoperatively which resulted in fatalities and injuries. the new approved specifications include a change in technology a control mechanism change as well as a modification to the canister vacuum level regulator [from mechanical to electrical]. the neptune 2 has been re-designed to address the hazards and harms outlined in previously recalls.