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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This recall is being conducted because a defect in the wire-reinforced tubing may result in a partial or total occlusion when the cuff is over-inflated. this may result in partial or total restriction of the air delivery to and/or from the patient.
Model Catalog: 8002001 (Lot serial: 3131039 to 31703855); Model Catalog: 8003001 (Lot serial: 3131039 to 31703855); Model Catalog: 8004001 (Lot serial: 3131039 to 31703855); Model Catalog: 8005001 (Lot serial: 3131039 to 31703855); Model Catalog: 8025001 (Lot serial: 3131039 to 31703855)