LivaNova Recalls Six Sorin Heater-Cooler Systems Due to Bacteria
LivaNova USA Inc. is recalling six Sorin Heater-Cooler System 3T units because post-cleaning water samples tested positive for nontuberculous mycobacteria.
- Product
- SORIN Heater-Cooler System 3T, REF 16-02-85 Intended for use with a Stockert/Sorin S3/S5/C5 heart-lung machine and/or any other heart-lung machine featuring a separate temperature control for extracorporeal perfusion of durations of up to 6 hours.
- Category
- Medical Device
- Distribution
- 3 states