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 has determined that there is a potential soldering defect with a single component identified on a limited number of uim pcba (user interface module printed circuit board assembly) received from their pcba supplier/manufacturer. this issue is limited to the colleague pump serial numbers listed. this soldering defect could lead to a delay or interruption of therapy.