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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Applied medical is conducting a voluntary recall of one specific lot of the ca500 epix universal clip applier due to a potential loading mechanism nonconformance. this may lead to clips not loading into the jaws requiring the user to actuate the trigger again to load a clip as per the instructions for use. patient harm is unlikely if the device is used as indicated in the instructions for use.