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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Smith medical has identified an issue with abl syringes when used with radiometer brand blood gas analyzers. in august 2013 smiths medical began receiving a small number of complaints regarding use of the abl syringes with radiometer blood analyzers. the plunger tip in the abl syringe does not remain stationary when the probe of the analyzer extends into the syringe. this allows air to leak into the sample at the luer stopping the blood from entering the analyzer probe and preventing the analysis of blood. this can result in difficulties aspirating the sample or the plunger may get pushed out of the syringe. smiths medical has received no reports of injury associated with this issue.