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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During a label review it was identified that the single and case label templates for discpac tip caps did not include the latex symbol. discpacs were shipped with a missing latex symbol on both single and case label artwork. the ifu correctly identifies the latex content. the heat shrink tape used on the discpac package is the only component that contains latex. the tape does not come into direct contact with the tip caps but must be peeled away and removed to access the self-righting tip caps.