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 in-house testing it was discovered that if the masks were squeezed too hard the plastic shell could crack resulting in the inability of the mask to ventilate.
Model Catalog: OL-500102-02 (Lot serial: 072111 through 040212); Model Catalog: OL-500101-02 (Lot serial: 072111 through 040212); Model Catalog: OL-500101-00 (Lot serial: 072111 through 040212); Model Catalog: OL-500102-00 (Lot serial: 072111 through 040212); Model Catalog: OL-500111-00 (Lot serial: 072111 through 040212); Model Catalog: OL-500100-00 (Lot serial: 072111 through 040212)