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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Manufacturer has had reports of these devices being occluded caused by inadequate lubrication applied to the slit in the upper seal of the valve boot.
Model Catalog: 2C8546 (Lot serial: ALL LOT NUMBERS); Model Catalog: 2C8864 (Lot serial: ALL LOT NUMBERS); Model Catalog: 2C8537 (Lot serial: ALL LOT NUMBERS); Model Catalog: 2C8519 (Lot serial: ALL LOT NUMBERS); Model Catalog: 2N8374 (Lot serial: ALL LOT NUMBERS); Model Catalog: 2N8378 (Lot serial: ALL LOT NUMBERS); Model Catalog: 2N8399 (Lot serial: ALL LOT NUMBERS); Model Catalog: 2C8606 (Lot serial: ALL LOT NUMBERS); Model Catalog: 2C8612 (Lot serial: ALL LOT NUMBERS); Model Catalog: 2C8632 (Lot serial: ALL LOT NUMBERS); Model Catalog: 2C8634 (Lot serial: ALL LOT NUMBERS); Model Catalog: 2C8571 (Lot serial: ALL LOT NUMBERS); Model Catalog: 2H8519 (Lot serial: ALL LOT NUMBERS)