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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False proximal occlusion alarms which cannot be cleared by the clinician can occur which will result in a delay or interruption in therapy and require the clinician to reset the alarm multiple times or replace the pump.
Model Catalog: 16026 (Lot serial: Software version 3.12); Model Catalog: 16027 (Lot serial: Software version 3.22); Model Catalog: 16026 (Lot serial: Software version 3.13); Model Catalog: 16027 (Lot serial: Software version 3.13); Model Catalog: 16026 (Lot serial: Software version 3.21); Model Catalog: 16027 (Lot serial: Software version 3.21); Model Catalog: 16026 (Lot serial: Software version 3.22); Model Catalog: 16026 (Lot serial: All serial numbers); Model Catalog: 16027 (Lot serial: All serial numbers); Model Catalog: 16027 (Lot serial: Software version 3.12)