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.
데이터 추가 비고
원인
There is potential for the "t" pressure adaptor a component of the inca infant nasal cannulae assemblies for cpapto have an obstruction in the outlet used for pressure monitoring. the injection mold tooling was identified to sporadically and in very limited. quatities create pieces ("t" pressure adaptors) where the in-pin insert was not sliding completely to its end point in the tool causing the obstruction in the outlet.