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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Teleflex medical is contacting customers that received the products referenced in this recall because the instructions for use (ifu) have been revied to include the following statement "for use with drugs approved for intransal delivery".
Model Catalog: MAD110 (Lot serial: >10 lot # Contact Mfg); Model Catalog: MAD130 (Lot serial: >10 lot # Contact Mfg); Model Catalog: MAD140 (Lot serial: >10 lot # Contact Mfg); Model Catalog: MAD100 (Lot serial: >10 lot # Contact Mfg); Model Catalog: MAD300 (Lot serial: >10 lot # Contact Mfg)