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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There is a potential of bolus delivery falilures when using the gemstar bolus cord. possible failures may be a result of cracked or damaged bolus cords which my result in an open or short circuit of the bolus cord. post-market incident reports indicate that the defects with these cords can lead to failure to deliver intermittent operation and unexpected delivery.