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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Maquet cardiopulmonary developed and validated new and revised cleaning and disinfection procedures for hcu 40 including a routine disinfection protocol and a protocol for highly effective disinfection also effective against atypical mycobacteria in the water system to be implemented on all hcu 40 systems in the field. the implementation of the new procedures for installed hcu 40 units requires an update by authorized maquet service personnel. customers will be notified and technicians will be dispatched to perform the updates and distribute new ifus.