Recall Z-1099-2019— LivaNova USA Inc.

Name: FDA recall Z-1099-2019
Creator: U.S. Food and Drug Administration
Published: 2018-09-14

Class II · Terminated

Class II FDA medical device recall by LivaNova USA Inc., initiated 2018-09-14, terminated 2022-09-14. It names one FDA 510(k) clearance: K052601. 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.. Reason: For six units, the post-deep cleaning (DC) water sample tested positive for nontuberculous mycobacteria (NTM)..

Recalling firm: LivaNova USA Inc.
Classification: Class II
Status: Terminated
Initiated: 2018-09-14
Terminated: 2022-09-14
Firm location: Arvada, CO, United States

510(k) clearances named in this recall

1 on FDA's record

K052601 — STOCKERT HEATER-COOLER SYSTEM 3TSorin Group Deutschland GmbH·cleared 2006-06-06

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.