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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Some units of theralite high cut off dialyzer from lot 1082 may have an incomplete seal of the sterile bag. if the sterile barrier is compromised and the product is used to treat a patient there is a remote risk of infection.