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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Stryker has discovered that there is potential for the product to be non-sterile. it was reported that there was a potential failure during routine maintenance of the sealing machine and it is likely to have caused unsuitable cross seals on the outer pouch. it was reported that there is potential for an unsterile inner pouch of the teflon tube due to missing seal integrity.