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
Sorin group usa has become aware of some aortic arch cannulae (part numbers na-55x7 and na-55x8 specific lot range) distributed in the market where the angle of the distal end may be less than specified. the cannulae consist of varying lengths of non-wire reinforced (flexible) polyvinyl chloride tubing that terminates in an angled tip. the defective cannulae are showing an angle that is about 15-20 degrees instead of approximately 45 degrees.