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FDA Safety Communication Update: Mycobacterium chimaera infections associated with 3T Heater-Cooler Systems

Update Oct 24th: You can also read Health Canada’s recall alert on this. The FDA has updated its June 1, 2016 Safety Communication to provide new information about Mycobacterium chimaera (M. chimaera) infections associated with the use of the LivaNova PLC (formerly Sorin Group Deutschland GmbH) Stӧckert 3T Heater-Cooler in U.S. patients who have undergone cardiothoracic surgeries. This communication also contains updated recommendations to help prevent the spread of infection...

Type: Post

Update Oct 24th: You can also read Health Canada’s recall alert on this. The FDA has updated its June 1, 2016 Safety Communication to provide new information about Mycobacterium chimaera (M. chimaera) infections associated with the use of the LivaNova PLC (formerly Sorin Group Deutschland GmbH) Stӧckert 3T Heater-Cooler in U.S. patients who have undergone cardiothoracic surgeries. This communication also contains updated recommendations to help prevent the spread of infection...