U.S. Food and Drug Administration recently issued the following announcement.
Date Initiated by Firm: September 14, 2018
Create Date: April 06, 2019
Recall Status: Completed
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 six units, the post-deep cleaning (DC) water sample tested positive for nontuberculous mycobacteria (NTM).
FDA Determined Cause: 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
Original source can be found here.
