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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Ansell had received several complaints regarding the scalpels in question. it was determined that the safety mechanism is not fully engaged and the blade tip could breach the packaging. this posses a safety issues for patients as this is a breach of the sterile barrier. in addition the user could be injured on the exposed blade.