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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Q core medical has identified a software issue with q core saphirre multi therapy and epidural pumps with each of the software version r11v53 change set 12333 12334 and 12998 that may create a potential risk of over-delivery in specific situations.No patient injuries or deaths have been reported as a results of this issue. however q core has determined there is a significant patient safety risk due to the potential for over-delivery.