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
Icu reported that certain lots of orbit 90 and orbit micro infusion sets may incur damage due to movement during shipping resulting in bent needles. the damage is easily detectible within the unopened sterile tray. if the needle cover is not attached to the needle and/or the needle is bent the device is damaged and should not be used.