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 for certain blood sets to puncture the outer wall of non-iso compliant blood bags. the iso piercing pin tip is sharper and longer than the port on the blood bag which is very short in certain non-iso blood bags and results in the leakage from the bag.