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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Certain vital signs breathing circuits may be provided with 15mm blue port caps as a loose component and/or 22mm blue port caps attached to certain circuit ports. they are not intended to be part of the final circuit assembly. if the circuit assembly is used with the cap in place it will cause occlusion of gas flow. occlusion of gas flow can result in varying degrees of hypoxia which may be severe.
Model Catalog: 1552016 (Lot serial: ALL LOTS); Model Catalog: 155200EU (Lot serial: ALL LOTS); Model Catalog: 1574723 (Lot serial: ALL LOTS); Model Catalog: 156205 (Lot serial: ALL LOTS); Model Catalog: 1553402 (Lot serial: ALL LOTS); Model Catalog: 156310 (Lot serial: ALL LOTS); Model Catalog: 1574710 (Lot serial: ALL LOTS); Model Catalog: 155518 (Lot serial: ALL LOTS)