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 amsco 400 steam sterilizers are designed for sterilization of heat and moisture stable materials used in healthcare facilities. the control board software is being revised to adjust the alarm set points such that the alarm is not erroneously triggered as the temperature of the sterilizer fluctuates during operation. when this alarm occurs the sterilizer locks up and cannot be used until serviced causing customer nuisance.