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
During an expanded review of records (see also recall number 53158) for the service activities performed by baxter corporation's local technical service centre it was found that required functional tests were potentially not performed on an additional number of colleague single channel and colleague triple channel volumetric infusion pumps.