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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The reason for the recall is that the sterile packaging may contain gaps in the seal of the pouch. if gaps are present the packaging integrity is compromised and there exists a chance that a non-sterile surgical light handle cover may be used during a surgical procedure.