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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Arrow international has issued this voluntary field corrective action because the labeling for the products listed above formerly referenced renografin-76 contrast medium (viscosity of 8.4 centipoise) which is no longer available. arrow is in the process of updating the labeling for these products. in the meantime when choosing alternative contrast medium health care providers are instructed to select a contrast medium with a viscosity of 8.4 centipoise or lower for use with the pressure and flow setting specified in the current ifu.