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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The tyvek cover (white lid) may not be completely sealed to the rest of the package allowing openings at the edge of the sterile package. the opening packaging of the affected product provides the opportunity for infectious agents and particulates matter to enter into the irrigation system and be transferred into the urinary tract.