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LivaNova Deutschland GmbH recalls 3T Heater Cooler System, REF: 16-02-85
Recalled October 18, 2023 · FDA recall Z-0073-2024 · LivaNova Deutschland
Hazard
The firm's labeling (Quick Reference Guide) contains incorrect information in the maintenance schedule for the Heater-Cooler device. · FDA Class II
Units
37 systems
Sold at
US Nationwide distribution in the states of CA, IN, GA, NC, TX, AZ, FL, MN, NJ, CO, SC.
Description
The firm's labeling (Quick Reference Guide) contains incorrect information in the maintenance schedule for the Heater-Cooler device.
Product
3T Heater Cooler System, REF: 16-02-85
Manufacturer(s)
LivaNova Deutschland GmbH
Made in
Germany
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →