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 became aware that the instructions for use (ifu) included with the low profile one piece dual stage venous return cannula was for another part number. the ifu included with the parts was for an arterial cannulae (catalogue number ra-xxxx). this issue affects this device model and lot only.