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 the potential for the heat shrink probe tip to be out of specification in the longitudinal change. this non-conformance may cause leakage issues which can be attributed to the heat shrink insulation thus allowing excessive shaft exposure.