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 is recalling the referenced product because these finished good kits may contain incorrect components. kits that should contain a 5 fr 2-lumen catheter may contain a 4 fr single lumen catheter and kits that should contain a 4 fr single lumen catheter may contain a 5 fr 2-lumen catheter. this labeling issue may cause a delay in treatment while a replacement catheter is obtained.