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 recall is being conducted as a precautionary measure due to out of specification (oos) results observed at the 24 month time point (out of 24-month licensed shelf life to expiration) during a coseal stability study. the parameter that is oos is an indicator of possible failure for the product to gel appropriately. all other stability requirements were met.