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
1)reduction in delivery accuracy may occur at programmed flow rates above 400ml/hr. 2)under worst case a flow deviaiton beyond labeled acceptable flow rate deviation may noccur which could lead to under infusion of medication.
Model Catalog: JC6395 (Lot serial: ALL LOTS); Model Catalog: JC5548N (Lot serial: ALL LOTS); Model Catalog: 2C6571 (Lot serial: ALL LOTS); Model Catalog: JC5381N (Lot serial: ALL LOTS); Model Catalog: 2C6572 (Lot serial: ALL LOTS); Model Catalog: 2C5587 (Lot serial: ALL LOTS); Model Catalog: JC7555 (Lot serial: ALL LOTS); Model Catalog: 2C7558 (Lot serial: ALL LOTS); Model Catalog: JC7564 (Lot serial: ALL LOTS); Model Catalog: JC7562 (Lot serial: ALL LOTS); Model Catalog: JC7560 (Lot serial: ALL LOTS); Model Catalog: JC7534 (Lot serial: ALL LOTS); Model Catalog: JC7527 (Lot serial: ALL LOTS); Model Catalog: 2C8858 (Lot serial: ALL LOTS); Model Catalog: 2C8857 (Lot serial: ALL LOTS); Model Catalog: 2C8571 (Lot serial: ALL LOTS); Model Catalog: 2H8864 (Lot serial: ALL LOTS); Model Catalog: 2C8860 (Lot serial: ALL LOTS); Model Catalog: 2C8864 (Lot serial: ALL LOTS); Model Catalog: 2H8860 (Lot serial: ALL LOTS); Model Catalog: 2C7564 (Lot serial: ALL LOTS); Model Catalog: 2C7560 (Lot serial: ALL LOTS); Model Cat