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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Based on one complaint and the subsequent investigation cordis has determined that selected lots of s.M.A.R.T. flex biliary stent system have a potential for cracked luer hubs due to a manufacturing error. the luer hub is used to inject contrast/saline during procedure preparation prior to insertion of the stent system into the patient. a cracked hub could result in leakage of saline or in the worst case inability to flush the outer sheath of the catheter.