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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Smiths medical reports the intermittent occurrence of binding of the locking assembly on some cadd-solis pumps. binding on the cassette/keypad lock can occur after latching the cadd-solis medication cassette reservoir or administration set disposable to the pump. when binding occurs it can prevent the key from fully rotating the cassette/keypad lock to the locked (engaged) position. to start an infusion with pump models 2111 and 2112 and model 2120 when in pca mode the lock must be fully engaged. this issue is limited to specific serial numbers only (1061043 through 1067598).