FIELD SAFETY NOTICE UPDATE Cardiac Surgery Mycobacterium Risks Disinfection and Cleaning of Sorin Heater Cooler Devices
In response to the Centers for Disease Control and Prevention’s (“CDC”’) Health Alert Network (“HAN”) and Morbidity and Mortality Weekly Report (“MMWR”) communications, and the related FDA Safety Communication, LivaNova has issued an updated Field Safety Notice to conduct customer outreach under which the company will proactively contact facilities to help implement the recommendations contained in the CDC HAN communication, the FDA Safety Communication, and the company’s previous recommendations.