medical Class II Updated 2019-04-17

LivaNova USA Inc. recalls SORIN Heater-Cooler System 3T, REF 16-02-85 Intended for

Recalled 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.

Hazard / Issue

For six units, the post-deep cleaning (DC) water sample tested positive for nontuberculous mycobacteria (NTM).

Issued by

FDA

Affected States: IN, MO, OH
Lot/Code Info: Serial numbers 16S13187, 16S14887, 16S15335, 16S15336, 16S15337, and 16S11877.
View official government recall

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