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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Sorin group italia has received customer complaints reporting a leak between the blood and water compartments of the heat exchanger used in the referenced oxygenators. the occurrence rate has been extremely low (less than 0.002%) and to date there have been no reports of any associated patient injuries.
Model Catalog: 067288004 (Lot serial: ALL LOTS); Model Catalog: 067288005 (Lot serial: ALL LOTS); Model Catalog: 087402700 (Lot serial: ALL LOTS); Model Catalog: 088116001 (Lot serial: ALL LOTS); Model Catalog: 088138500 (Lot serial: ALL LOTS); Model Catalog: 067288003 (Lot serial: ALL LOTS); Model Catalog: 089106900 (Lot serial: ALL LOTS); Model Catalog: 086111500 (Lot serial: ALL LOTS)