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
An anomaly seen with the nucletron adapter and transfer guide tube and set part numbers: al13005001 and al13005000. in some instances of the adapters the locking mechanism provides insufficient holding force for the transfer guide tubing.