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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The core suction irrigation handpieces are sold as sterile single use devices. conmed has identified certain core suction irrigation product with creases in the packaging seal which sometimes result in an open channel. these channels may compromise sterility of the product. in no instance has it been reported to conmed that a compromise in the sterile barrier has resulted in illness or injury.