Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1099-2019 — 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.

U.S. FDA — Device Enforcement · United States · 2018-09-14 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1099-2019
Date of alert
2018-09-14
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
LivaNova USA Inc.
Product category
device
Product type
Devices
Reported risk: For six units, the post-deep cleaning (DC) water sample tested positive for nontuberculous mycobacteria (NTM).
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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