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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This product recall has been initiated as a result of the product from lot number 59860969 failing to meet the established statistical test for heparin activity. catheters in this lot may be below the low end specification for heparin activity.