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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Safety alert communication issued for additional instruction in some cases not included on labeling for viaflex container with connector: do not use flexible solution container if the administration port protector is not in place prior to use. baxter requested customers to not use flexible solution containers if the administration protector is not in place. the port protector serves as a sterility barrier and if port protector missing sterility of administration port may be compromised potentially placing atients at risk of blood stream infection due to microbial contamination introduced to the fluid path. no associated deaths or serious injury related to this issue.