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 reason for this recall is the result of a confirmed us customer complaint of an open seal on the top portion of the package. medline confirmed the customer complaint and promptly put all other inventory with this lot number on quarantine for further investigation. no other packages from this lot were confirmed to have open seals during the investigation. as a precautionary measure medline is issuing a recall for this specific lot of gloves.