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 door roller assembly on the plum lifecare 5000 series and plum xl infuser families has the potential to break which can lead to possible unrestricted flow and/or overdelivery when the door of the pump is opened.
Model Catalog: 11859 (Lot serial: All Serial Numbers); Model Catalog: 11846 (Lot serial: All Serial Numbers); Model Catalog: 11781 (Lot serial: All Serial Numbers); Model Catalog: 11555 (Lot serial: All Serial Numbers); Model Catalog: 11845 (Lot serial: All Serial Numbers); Model Catalog: 2507 (Lot serial: All Serial Numbers)