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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Smiths medical is recalling all level 1 normothermic iv fluid administration sets equipped with the f-50 gas vent filter assembly (gvfa) from the market and temporarily suspending all sales of these products because of complaints of kinking of the tubing and leaking of the f-50 gvfa. in some cases kinking in the tubing or leaking of the f-50 gvfa can cause a decrease in fluid flow rate.