Recall Z-1901-2018— LivaNova USA

Name: FDA recall Z-1901-2018
Creator: U.S. Food and Drug Administration
Published: 2018-04-20

Class II · Terminated

Class II FDA medical device recall by LivaNova USA, initiated 2018-04-20, terminated 2025-02-05. It names one FDA 510(k) clearance: K052601. Product: Sorin Stockert Heater-Cooler System 3T, a) Item #: 16-02-81, 240 v/60 Hz; b) Item #: 16-02-82, 208 v/60 Hz; c) Item #: 16-02-85, 120 v/60 Hz. Reason: Firm is notifying customers that the Deep-Cleaning Service is now available in the United States. Stockert Heater-Cooler System 3T devices are suspected of microbial contamination and may contain visible biofilm..

Recalling firm: LivaNova USA
Classification: Class II
Status: Terminated
Initiated: 2018-04-20
Terminated: 2025-02-05
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 Stockert Heater-Cooler System 3T, a) Item #: 16-02-81, 240 v/60 Hz; b) Item #: 16-02-82, 208 v/60 Hz; c) Item #: 16-02-85, 120 v/60 Hz

Reason for recall

Firm is notifying customers that the Deep-Cleaning Service is now available in the United States. Stockert Heater-Cooler System 3T devices are suspected of microbial contamination and may contain visible biofilm.

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