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 packaging of some non sterile non patient use demonstration fiber-optic iabc the ferrule cap was not removed.If the connector is inserted into patient use maquet cs300cardiosave intra-aortic balloon pump or iabp upgraded with fiber optic module cap may become dislodged and remain in receptacle of pump.