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 is being initiated for the specific lot number 6173030 due to incorrect packaging. cook medical has received one report of packages labeled as 5.0fr actually containing 6.0fr devices. the event is not likely to lead to an adverse patient or user outcome.