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.
데이터 추가 비고
원인
Baxter corporation has initiated an important product information communication regarding the coiled tube infusor system. recent testing has shown that the nominal flow rate as labeled is achieved when the elastomeric reservoir is positioned 15cm-20cm (6-8 inches) below the distal luer lock and not when positioned at the same height as stated in the directions for use.