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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A defect with the resin used in tubing received from a supplier has been discovered. this has resulted in a rough texture on the inner and outer diameter of the tubing segment inserted into the pump. this could lead to the pump sensor registering an air bubble causing an unresolvable false air-in-line alarm even if no air bubble is present.