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
Baxter has identified a labeling issue affecting all lots of extension sets 2n3347 and 2n3350 whereby the product configuration and label illustration have the slide clamp above the filter but the written instructions tell the user to close the clamp below filter when set is not in use. the current clamp configuration could result in the unintended fluid administration of approximately 0.2ml.