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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The wire packages are correctly marked with a 'non-sterile' label however the enclosed instructions for use (ifu) states the devices are sterilized via gamma irradiation and should not be re-sterilized. since the ifu states the devices are sterile no instructions for moist heat sterilization are provided. because the ifu does not provide information regarding sterilization the hospital staff may be confused.
Model Catalog: 2704-3-018 (Lot serial: >10 lot numbers contact mfg); Model Catalog: 6703-1-018 (Lot serial: >10 lot numbers contact mfg); Model Catalog: 6704-1-018 (Lot serial: >10 lot numbers contact mfg); Model Catalog: 6704-3-120 (Lot serial: >10 lot numbers contact mfg)