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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Manufacturer has identified one potential root cause of blood contamination in the blood lines in heamodialysis machines as the tranducer protectors.
Model Catalog: 205-053SUS (Lot serial: ALL LOT NUMBERS); Model Catalog: 205-053E (Lot serial: ALL LOT NUMBERS); Model Catalog: 205-053ETH (Lot serial: ALL LOT NUMBERS); Model Catalog: 205-054E/C (Lot serial: ALL LOT NUMBERS)