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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During an inspection of finished product terumo cardiovascular systems (terumo cvs) identified the presence of loose fiber particulate that exceeded specification for the finished sarns and terumo cannulae. terumo cvs has not received any reports of loose particulate during clinical use. tcvs has decided to remove all affected lots that were distributed.