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 corporation is issuing an urgent medical device correction for the ultrafilter u9000 lot numbers listed below due to leaks during regular clinical use in conjunction with artis ak98 and ak96 dialysis machines. the leaks are caused by cracks near the header cap due to the stress of repeated disinfection cycles over the lifetime of the product. a leaking ultrafilter u9000 could lead to excessive fluid removal during dialysis and subsequently hypovolemia.