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.
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Potential for an unintended infusion rate when the outlook pump is used in dose mode in a manner that is inconsistent with the instructions in the operating manual.
Model Catalog: 620-100 (Lot serial: software version 151431); Model Catalog: 620-100 (Lot serial: software version 151441); Model Catalog: 620-100 (Lot serial: software version 151423); Model Catalog: 620-100 (Lot serial: software version 151447)