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 a voluntary product recall for one (1) lot of revaclear max dialyzers due to the potential presence of particulate matter within the blood side of the dialyzer. the issue was identified as a result of one customer complaint received for the presence of black fibers and dust within the dialyzer. there is the potential of visually not detecting the presence of foreign material in the blood side of the dialyzer. when the dialyzer is used the particles may become dislodged by flow of the dialysate and may reach the vascular system of the patient which could lead to adverse health consequences. there have been no reports of injuries associated with this issue.