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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During an in-house inspection terumo cardiovascular systems (terumo cvs) identified the presence of excess plastic material or flash on a proportion of connectors used for the sarns flexible arterial cannula and the sarns high-flow aortic arch cannula. the flash originated from a molding tool and is located on the exterior of the connector. there is a potential for the flash to detach. terumo cvs is advising users to discontinue use and return all affected cannulae in inventory.