Class 2 Device Recall Stockert HeaterCooler System 3T

• Date Initiated by Firm: November 01, 2018
• Create Date: October 25, 2019
• Recall Status: Terminated on August 04, 2022
• Recall Number: Z-0220-2020
• Recall Event ID: 83822
• 510(K)Number: K052601
• Product Classification: Controller, temperature, cardiopulmonary bypass - Product Code DWC
• Product: SORIN Heater-Cooler System 3T 120V~/60Hz; REF 16-02-85; ; Description of product:; The St¿ckert Heater-Cooler System is an independent (i.e. independent of the water supply) 3-circuit-heating/cooling system. The three separate water circuits have been developed to serve as:; " Two circuits for the patient supplied by one tank (for the heating/cooling blanket and the heat-exchanger associated with the oxygenator), common temperatures ranging from 2 degrees Celsius to 41 degrees Celsius, tank volume 6 liters.; " One interchangeable heating/cooling circuit for cardioplegia heat-exchanger,; temperatures ranging from 2 degrees Celsius to 10 degrees Celsius (cooling tank) and/or from 15 degrees Celsius to 41 degrees Celsius (heating tank).; ; If required, the circuits for the patient and the circuit for cardioplegia can be switched off separately, in order to increase the activated functional group s heating and/or cooling performance. Product Usage: The Stockert Heater-Cooler System 3T is 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: 16-02-80 Stockert Heater-Cooler System 3T, 230V, Serial #s 16S10027 thru 16S16874 16-02-81 Stockert Heater-Cooler System 3T, 240 v/60 Hz, Serial #s 16S10743 thru 16S11708 16-02-82 Stockert Heater-Cooler System 3T, 208 v/60 Hz, Serial #s 16S10772 thru 16S16840 16-02-83 Stockert Heater-Cooler System 3T, 127V/60Hz, Serial #s 16S11455 thru 16S16509 16-02-85 Stockert Heater-Cooler System 3T, 120 v/60 Hz, Serial #s 16S10958 thru 16S16847 16-02-95 Stockert Heater-Cooler System 3T, 200V/50Hz/60Hz, Serial #s 16S12004 thru 16S16818
• Recalling Firm/ Manufacturer: LivaNova USA Inc.; 14401 W 65th Way; Arvada CO 80004-3503
• For Additional Information Contact: Joan Ceasar; 303-467-6306
• Manufacturer Reason for Recall: The firm has become aware that due to a chemical reaction, the disinfectant/water preservative used to disinfect the device to inhibit/limit the growth micro-organisms, may be rendered ineffective. In addition, the firm is releasing a design upgrade to reduce the risk of potential emission of aerosols from the 3T.
• FDA Determined Cause: Device Design
• Action: On 10/18/2018, the firm sent a certified "MEDICAL DEVICE CORRECTION" Letter to its customers informing them that due to a chemical reaction, the disinfectant/water preservative (hydrogen peroxide) used to disinfect the device to inhibit/limit the growth micro-organisms, may be rendered ineffective. The letter advises customers to: -Daily Hydrogen Peroxide Monitoring: Users should monitor the hydrogen peroxide concentration in the water solution on a daily basis to verify that sufficient concentration of hydrogen peroxide is present in the water circuit of the device. A decrease in hydrogen peroxide over the 7-day-period until the next water change is expected, however the hydrogen peroxide concentration should remain above 100 ppm. Detailed instructions are provided in Attachment 1, titled Daily Hydrogen Peroxide Monitoring Instructions (included in the Customer Notification Letter). Customers are instructed to read the detailed instructions carefully and to follow them. -3T Design Upgrade: The Recalling Firm has developed a vacuum canister and internal sealing design change that is intended to further mitigate (but does not eliminate) the risk of airborne transmission of non-tuberculosis mycobacterium ( NTM ) from the 3T device. Important instructions that ensure the effectiveness of this modified design will be provided at the time of the upgrade. A Firm representative or local agent will contact its customers to plan the upgrade of their affected products. No other actions by the user are required at this time, other than to continue to follow the 3T Operating Instructions and the attached Daily Hydrogen Peroxide Monitoring Instructions, and to return the Customer Response Form. For those users that have devices undergoing deep cleaning, your device will be upgraded at the deep cleaning facility. Customers are instructed to please complete and return the attached Customer Response Form by fax to (303) 467-6502 or by email to USFSN@livanova.com. Cu
• Quantity in Commerce: 8671
• Distribution: Worldwide distribution - US Nationwide distribution including sate of PR and countries of Albania, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Estonia, Ethiopia, Finland, France, Georgia, Germany, Greece, Guatemala, Guyana, Hong Kong, Hungary, India, Indonesia, Iran (Islamic Republic of), Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea (the Republic of), Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Macedonia (the former Yugoslav Republic of), Malaysia, Maldives, Malta, Mauritius, Mexico, Monaco, Mongolia, Montenegro, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Peru, Philippines (the), Poland, Portugal, Qatar, Romania, Russian Federation (the), Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Syrian Arab Republic, Taiwan (Province of China), Thailand, Trinidad and Tobago, Tunisia, Turkmenistan, Turkey, Ukraine, United Arab Emirates (the), United Kingdom, Uruguay, Uzbekistan, Vietnam.
• 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