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
Connector component used in a previous version of its cpap masks may fail prematurely if improperly cleaned.
Model Catalog: HC401A (Lot serial: 900HC402 LOT#010918 TO 060203); Model Catalog: HC401A (Lot serial: 900HC412 LOT#020108 TO 060203); Model Catalog: HC401A (Lot serial: 900HC401X LOT#010829 TO 020517); Model Catalog: HC401A (Lot serial: HC401A LOT#020521 TO 060217); Model Catalog: HC452F (Lot serial: 900HC463 LOT#020108 TO 040604); Model Catalog: HC452A (Lot serial: 900HC463 LOT#020108 TO 040604); Model Catalog: HC451A (Lot serial: 900HC463 LOT#020108 TO 040604); Model Catalog: 900HC451T (Lot serial: 900HC463 LOT#020108 TO 040604); Model Catalog: 900HC451 (Lot serial: 900HC463 LOT#020108 TO 040604); Model Catalog: HC452F (Lot serial: 400HC209 LOT#041108 TO 050920); Model Catalog: HC452A (Lot serial: 400HC209 LOT#041108 TO 050920); Model Catalog: HC451A (Lot serial: 400HC209 LOT#041108 TO 050920); Model Catalog: 900HC451T (Lot serial: 400HC209 LOT#041108 TO 050920); Model Catalog: 900HC451 (Lot serial: 400HC209 LOT#041108 TO 050920); Model Catalog: HC452F (Lot serial: HC452F LOT#040719 TO 041102); Model Catal