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LivaNova USA Inc. recalls LivaNova Heater-Cooler System 3T - Product Usage: The Heater-Cooler 3T System is used to circulate water through heat ex
Recalled March 25, 2020 · FDA recall Z-1498-2020 · LivaNova USA
Hazard
The firm is providing validated cleaning and disinfection instructions in their revised operating instructions to reduce the risk of NTM contamination. · FDA Class II
Units
Total Worldwide=9309 systems (2713 system in U.S.)
Sold at
U.S. Nationwide distribution including Puerto Rico. This matter was triggered by the clearance of K191402, thus only the United States, including Puerto Rico, is affected. O.U.S. - none
Description
The firm is providing validated cleaning and disinfection instructions in their revised operating instructions to reduce the risk of NTM contamination.
Product
LivaNova Heater-Cooler System 3T - Product Usage: The Heater-Cooler 3T System is used to circulate water through heat exchangers to warm or cool a patient during cardiopulmonary bypass procedures lasting 6 hours or less.
Manufacturer(s)
LivaNova USA Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →