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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Potential for damage to pouch seal during transport resulting in breach of sterile barrier.
Model Catalog: 080-501 (Lot serial: >100 number contact mfg); Model Catalog: 080-271 (Lot serial: >100 number contact mfg); Model Catalog: 080-351 (Lot serial: >100 number contact mfg); Model Catalog: 080-401 (Lot serial: >100 number contact mfg); Model Catalog: 080-451 (Lot serial: >100 number contact mfg); Model Catalog: 080-481 (Lot serial: >100 number contact mfg)