SORIN Heater-Cooler System 3T 120V~/60Hz REF 16-02-85 Description of product: The St¿ckert H...
FDA Device Recall #Z-0220-2020 — Class II — November 1, 2018
Recall Summary
| Recall Number | Z-0220-2020 |
| Classification | Class II — Moderate risk |
| Date Initiated | November 1, 2018 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | LivaNova USA Inc. |
| Location | Arvada, CO |
| Product Type | Devices |
| Quantity | 8671 |
Product Description
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.
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.
Distribution Pattern
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.
Lot / 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
Other Recalls from LivaNova USA Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2457-2020 | Class II | Sterile Disposable Connectors ASY 1/2 CONN W/LL... | Apr 24, 2020 |
| Z-2464-2020 | Class II | Vein Irrigation Cannula with blunt tip. ASY VIC... | Apr 24, 2020 |
| Z-2456-2020 | Class II | Sterile Disposable Connectors ASY RDC Y 1/2X3/8... | Apr 24, 2020 |
| Z-2463-2020 | Class II | Vein Irrigation Cannula with blunt tip. ASY BIC... | Apr 24, 2020 |
| Z-2447-2020 | Class II | Sterile Disposable Connectors ASY STR CONN 1/4 ... | Apr 24, 2020 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.