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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An issue was identified with the stiffer coaxial micro-introducer 4fr and 5fr after a field complaint reported that the rotating luer detached from the dilator hub during use. the function of the rotating luer is to fasten the dilator to the shield during insertion. affected lots have an outer diameter of the dilator hub that is slightly smaller than is capable of securing the dilator to the sheath.