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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Baxter is issuing a recall for a specific product code and lot number due to the potential presence of leaks. a leak may allow for microbial contamination of the sterile fluid path. if not detected the use of a bag with leak could lead to a bloodstream infection or other serious adverse health consequences. there have been no reports of adverse events associated with this issue for leaks.