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.
ICU Medical, Inc. acquired from Pfizer in early 2017, Hospira Infusion Systems, the portion of Hospira dedicated to develop infusion pumps.
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Some plum 360 and plum a+ infusion pumps were not properly calibrated during the manufacturing process. as a result the impacted pumps can potentially produce false proximal occlusion alarms during cassette initialization (set-up of the therapy) or the alarm may be delayed in the case of a proximal occlusion during delivery (therapy).