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LivaNova USA Inc. recalls SORIN Heater-Cooler System 3T, REF 16-02-85 Intended for use with a Stockert/Sorin S3/S5/C5 heart-lung machine and/or
Recalled April 17, 2019 · FDA recall Z-1099-2019 · LivaNova USA
Hazard
For six units, the post-deep cleaning (DC) water sample tested positive for nontuberculous mycobacteria (NTM). · FDA Class II
Units
6 devices
Sold at
US Distribution to states of: IN, MO, and OH.
Description
For six units, the post-deep cleaning (DC) water sample tested positive for nontuberculous mycobacteria (NTM).
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.
Manufacturer(s)
LivaNova USA Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →