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LivaNova USA Inc. recalls SORIN Heater-Cooler System 3T 120V~/60Hz REF 16-02-85 Description of product: The St¿ckert Heater-Cooler System is
Recalled November 6, 2019 · FDA recall Z-0220-2020 · LivaNova USA
Hazard
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 Class II
Units
8671
Sold at
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.
Description
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.
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.
Manufacturer(s)
LivaNova USA Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →