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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Bard is notifying customers of incorrect lumen gauge size labeling on some per-q-cath products. bard identifies catheter size in two ways on this product by french size and gauge size. the french size is not affected and is correct for these products. product is not required to be removed as the product functions as intended and is manufactured according to design specifications with the correct french size designation.