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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Potential occlusion (partial or total) of the set of the arterial (red) connector to the dialyzer which could pose a risk of hemodialysis to patient.
Model Catalog: 003410-710 (Lot serial: 03P158XXX ALL LOTS); Model Catalog: 0141080XXXC (Lot serial: 03P158XXX ALL LOTS); Model Catalog: 003410-510 (Lot serial: 04P158111 AND BELOW); Model Catalog: 003410-710 (Lot serial: 04P158111 AND BELOW); Model Catalog: 0141080XXXC (Lot serial: 04P158111 AND BELOW); Model Catalog: 003410-510 (Lot serial: 0XP15XXXX ALL LOTS); Model Catalog: 003410-710 (Lot serial: 0XP15XXXX ALL LOTS); Model Catalog: 0141080XXXC (Lot serial: 0XP15XXXX ALL LOTS); Model Catalog: 003410-510 (Lot serial: 04P158215 AND BELOW); Model Catalog: 003410-710 (Lot serial: 04P158215 AND BELOW); Model Catalog: 003410-510 (Lot serial: 03P158XXX ALL LOTS); Model Catalog: 0141080XXXC (Lot serial: 04P158215 AND BELOW)