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
This voluntary action is a medical device correction to update the user manual to modify the inspection process for the 5mm cannula and 5mm flared cannula. the 5mm cannula has been shown to be safe and effective when used in accordance with product labeling but can be damaged or bent by inappropriate handling this action instructs the user how to objectively inspect 5mm cannulas prior to use.