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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Icu medical has identified a potential for the connectivity engine (ce) module to disengage from the main chassis. in a rare situation this could lead the plum 360 infuser to power down without an alarm notification resulting in a delay of either initiation of a therapy or interruption of an active infusion.