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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The carefusion airlife heated infant breathing circuit is being recalled due to a regulatory compliance risk involving a material change. the changes to the gas pathway material may potentially impact the safety of the device and quality of the gas condensates to the patient.
Model Catalog: 10127-4H1 (Lot serial: ALL LOTS); Model Catalog: 1208-4H1 (Lot serial: ALL LOTS); Model Catalog: RC51-12002 (Lot serial: ALL LOTS); Model Catalog: 9054-4S2 (Lot serial: ALL LOTS); Model Catalog: RT4851-00 (Lot serial: ALL LOTS); Model Catalog: RT4851-18 (Lot serial: ALL LOTS)