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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Coopersugical has updated the instructions for use (ifu) for the milex pessaries. the change was made to clarify and update the patient cleaning section of previous versions of the instructions for use (ifu). coopersurgical therefore is sending an advisory notification to all affected customers and provide them with copies of the newly updated and approved instructions for use (ifu rev a - 2/12).