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.
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The broselow/hinkle intraosseus module which is part of the broselow/hinkle pediatric emergency system contains a 15g intraosseus needle that is not compatible with the iv extension set that is provided in the module. this may result in a leak at the connection and delay treatment.
Model Catalog: 7730PUR5 (Lot serial: 001K to 149K inclusive); Model Catalog: 7730RED5 (Lot serial: 001K to 149K inclusive); Model Catalog: 7730ORG5 (Lot serial: 001K to 149K inclusive); Model Catalog: 7730MOD (Lot serial: 001K to 149K inclusive); Model Catalog: 7730IALS (Lot serial: 001K to 149K inclusive); Model Catalog: 7730GRN5 (Lot serial: 001K to 149K inclusive); Model Catalog: 7730BLU5 (Lot serial: 001K to 149K inclusive); Model Catalog: 7730ALS (Lot serial: 001K to 149K inclusive); Model Catalog: 7730YEL5 (Lot serial: 245F to 366F inclusive); Model Catalog: 7730WHI5 (Lot serial: 245F to 366F inclusive); Model Catalog: 7730RED5 (Lot serial: 245F to 366F inclusive); Model Catalog: 7730PUR5 (Lot serial: 245F to 366F inclusive); Model Catalog: 7730ORG5 (Lot serial: 245F to 366F inclusive); Model Catalog: 7730MOD (Lot serial: 245F to 366F inclusive); Model Catalog: 7730IALS (Lot serial: 245F to 366F inclusive); Model Catalog: 7730GRN5 (Lot serial: 245F to 366F inclusive); Model Catalog: 7730BLU5 (Lot seria