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
Atrium trocar catheters are packaged with a label containing an icon that shows more holes (eyelets) than the product actually contains. this graphical icon shows there are 6 side holes on the trocar catheter.
Model Catalog: 8432 (Lot serial: All lots); Model Catalog: 8428 (Lot serial: All lots); Model Catalog: 8424 (Lot serial: All lots); Model Catalog: 8408 (Lot serial: All lots); Model Catalog: 8416 (Lot serial: All lots); Model Catalog: 8412 (Lot serial: All lots); Model Catalog: 8410 (Lot serial: All lots); Model Catalog: 8420 (Lot serial: All lots)