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
The outer pouch packaging used on some portex branded epidural and spinal needle sets may have insufficient seal.In some cases the final seal of the tyvek packaging is insufficient to assure microbial barrier.
Model Catalog: 100/496/122 (Lot serial: 241387 TO 481245); Model Catalog: 100/496/126 (Lot serial: 279773 TO 477029); Model Catalog: 100/496/124 (Lot serial: 279773 TO 477029); Model Catalog: 100/496/126 (Lot serial: 277196 TO 480812); Model Catalog: 100/496/124 (Lot serial: 277196 TO 480812); Model Catalog: 100/496/122 (Lot serial: 277196 TO 480812); Model Catalog: 100/496/124 (Lot serial: 241387 TO 481245); Model Catalog: 100/496/126 (Lot serial: 241387 TO 481245); Model Catalog: 100/496/122 (Lot serial: 279773 TO 477029)