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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This recall has been initiated due to the presence of bacterial endotoxins levels for some revolve units are above the acceptable limits as defined in the standard usp <161> ("medical devices - bacterial endotoxin and pyrogen tests"). the issue was self identified/confirmed on may 4 2017.