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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A manufacturing fault in the tube supplied to intersurgical for production of the device can result in partial or total occlusion of the airway tube when the cuff is inflated which may result in partial or total restriction of air delivery to and/or from the patient.
Model Catalog: 8025001 (Lot serial: 31310139 to 31703855); Model Catalog: 8002001 (Lot serial: 31310139 to 31703855); Model Catalog: 8005001 (Lot serial: 31310139 to 31703855); Model Catalog: 8003001 (Lot serial: 31310139 to 31703855); Model Catalog: 8004001 (Lot serial: 31310139 to 31703855)