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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Baxter corporation has initiated a recall for the listed devices due to an increase in complaints for leaks at the distal male luer and luer cap. baxter has resolved the issue and has since implemented enhancements to the blue winged cap to improve the seal between the cap and the luer. complaint rates for leaks have since decreased. baxter wants to ensure that no affected product remains in the field.