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
During functional testing it was determined that product failed to meet shelf-life at the expiration date indicated on the product labels. this action is due to product misbranding. the expiration date is not supported by the real time aging collected. there are no associated immediate or long range health consequences anticipated from the use of or exposure to the defective device.