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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Certain plum a+ family infusion pumps in which the audio level rotary knob does not rotate in accordance with the information in the systems operating manual (som). the som indicate a clockwise rotation of the knob will decrease the alarm volume however in some plum a+ devices it has been found that the volume increases when the knob is turned clockwise.
Model Catalog: 11006 (Lot serial: All Serial numbers); Model Catalog: 11005 (Lot serial: All Serial numbers); Model Catalog: 20677 (Lot serial: All Serial numbers); Model Catalog: 12097 (Lot serial: All serial numbers); Model Catalog: 20792 (Lot serial: All serial numbers); Model Catalog: 20791 (Lot serial: All serial numbers); Model Catalog: 12391 (Lot serial: All serial numbers); Model Catalog: 20679 (Lot serial: All serial numbers)