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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Smiths medical has become aware of an increased trend in reports of kinking of the tubing on certain sets. in some cases the kink may lead to a decrease in the flow of fluid to the patient. a reduction in flow rate may lead to a delay of therapy which could result in patient injury or death.