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U.S. Department of Health and Human Services

Class 2 Device Recall Stockert/Sorin HeaterCooler System 3T

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  Class 2 Device Recall Stockert/Sorin HeaterCooler System 3T see related information
Date Initiated by Firm September 14, 2018
Create Date April 06, 2019
Recall Status1 Terminated 3 on September 14, 2022
Recall Number Z-1099-2019
Recall Event ID 82365
510(K)Number K052601  
Product Classification Controller, temperature, cardiopulmonary bypass - Product Code DWC
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.
Code Information Serial numbers 16S13187, 16S14887, 16S15335, 16S15336, 16S15337, and 16S11877.
Recalling Firm/
Manufacturer		 LivaNova USA Inc.
14401 W 65th Way
Arvada CO 80004-3503
Manufacturer Reason
for Recall		 For six units, the post-deep cleaning (DC) water sample tested positive for nontuberculous mycobacteria (NTM).
FDA Determined
Cause 2		 Material/Component Contamination
Action The recalling firm, LivaLova, contacted the first customer by phone on 9/14/2018 followed by an "IMPORT" letter, the first of which was dated 9/18/2018. The letter described the product, problem and actions to be taken. The customers were instructed to do the following: keep these devices out of service until the investigation is complete. To return your device, please email 3T.US@livanova.com. If taking Serial Numbers 16S15335 and 16S15337 out of service will negatively impact your clinical practice, we can arrange for delivery of loaner devices during this investigation and,as necessary, while they undergo repeat Deep Cleaning Process. If you have any questions, contact V.P., Clinical, Quality, and Regulatory Services at 303-467-6306 or email: joan.ceasar@livanova.com.
Quantity in Commerce 6 devices
Distribution US Distribution to states of: IN, MO, and OH.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = DWC and Original Applicant = SORIN GROUP DEUTSCHLAND GMBH
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