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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Baxter sent an addendum for the support material to address a situation if patients turn off the verify initial drain alrm volume and how to respond to system errors 2240 and 2267emergency disconnect procedure.
Model Catalog: 5C8310 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 5C8310PE (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 5C8310P (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 5C4471 (Lot serial: ALL SERIAL NUMBERS)