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
The exp. date of the sterile pouched guidewire was not considered when exp. dating was calculated for the finished device. cannot assure sterility or function of the guidewire beyond its exp date.
Model Catalog: (Lot serial: LOT 544202 EXP 11-2009); Model Catalog: (Lot serial: LOT 546614 EXP 09-2010); Model Catalog: (Lot serial: LOT 545693 EXP 05-2010)