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 an important product information for the colleague pump (p1.7a) to remind users to reset the manual tube release (mtr) when it is left in the open position. users that do not follow the labeled instructions for resetting the mtr prior to use will be unable to power on the device. this has the potential to lead to a delay in therapy as the device will not power on.