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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Some plum a+/a+3 devices contain a communication engine which communicates wirelessly with hospira mednet over a customer facility local area network (lan). hospira has received several reports indicating that the communication engine in some plum a+/a+3 devices experiences difficulty downloading a custom drug library. this will result in failure to the ce pwa on the plum a+ infusion pumps/modules which results in stuck in pending or unable to download a drug library.
Model Catalog: 20791-XX-YY (Lot serial: All Serial Numbers); Model Catalog: 20677-XX-YY (Lot serial: All Serial Numbers); Model Catalog: 20678-XX-YY (Lot serial: All Serial Numbers); Model Catalog: 12391-XX-YY (Lot serial: All Serial Numbers); Model Catalog: 20792-XX-YY (Lot serial: All Serial Numbers)