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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Therakos has received an increased rate of complaints related to leaks at tubing connections for certain lots of therakos uvar xts procedural kits. internal investigation has determined that a raw material used in the manufacture of the kit is causing leaks to occur in certain lots.