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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Smith & nephew has identified that the process of folding the sterile renasys transparent film pouch during its packaging has the potential to damage the pouch seals resulting in a loss of sterility of the product. the loss of sterility has the potential to contribute to a local infection.