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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Greatbatch reports that recent sterilization testing performed in a dedicated instrument case revealed that the device did not meet an acceptable sterility assurance level using the sterilization parameters identified in ifu man-000002 rev d. the location of the failure was under the pom-c (blue) handle.