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
1. moulding flash during manufacturing of t-piece at supplier caused out of specification aperture. 2. severity in risk analysis control document (rac) scored low leading to less strict supplier inspection and process control requirements.
Model Catalog: M1091335 (Lot serial: NON AVAILABLE); Model Catalog: M1091365 (Lot serial: NON AVAILABLE); Model Catalog: M1091316 (Lot serial: NON AVAILABLE)