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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Baxter is issuing a recall for the product codes and lots listed due to the potential for incomplete dissolution of the polyethylene glycol (peg) component during the reconstitution of the product which may affect the consistency of the hydrogel formation during use.