FDA-Device2019-04-17Class II
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.
LivaNova USA Inc.
Hazard
For six units, the post-deep cleaning (DC) water sample tested positive for nontuberculous mycobacteria (NTM).
Sold states
US Distribution to states of: IN, MO, and OH.
Affected count
6 devices
Manufactured in
14401 W 65th Way, N/A, Arvada, CO, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1099-2019Don't want to check this manually?
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