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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A potential carton labeling discrepancy has been identified in association with 0.45% saline solution bottles. the lot number and expiration date indicated on the carefusion label applied to a shipping carton does not match the lot number and expiration date of the affixed biomerieux barcode label. the saline solution 0.45% is used in conjunction with the vitek 2 system for organism identification and/or antimicrobial susceptibility testing.