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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Leak at the return luer connection on 2 mfr lots of cobe spectra white blood cell disposable tubing sets. leak is observed as a very small fluid leak originating between the male luer on the return line and the attached customer needle or as an observation of air in the line when blood warmer tubing is attached to the male luer.