CLASS II Device recall · Reported 6 Nov 2019 · FDA Enforcement Report
The St¿ckert Heater-Cooler System is an independent (i.e recalled
LivaNova USA is recalling The St¿ckert Heater-Cooler System is an independent (i.e, distributed nationwide in the US. The recall was initiated on 1 Nov 2018 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0220-2020
- FDA event ID
- 83822
- Recalling firm
- LivaNova USA, Arvada, CO
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 1 Nov 2018
- FDA classified
- 25 Oct 2019
- Reported
- 6 Nov 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Temperature Abuse
- Device type
- Other Medical Devices
Timeline
| 1 Nov 2018 | Recall initiated by company | |
| 25 Oct 2019 | Classified by FDA | +358 days |
| 6 Nov 2019 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Foods that need refrigeration and were stored or shipped too warm can grow harmful bacteria without any change in look or smell.
Product as listed by the FDA
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.
Where it was distributed
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.
Questions about this recall
Is The St¿ckert Heater-Cooler System is an independent (i.e recalled?
Yes. LivaNova USA recalled The St¿ckert Heater-Cooler System is an independent (i.e on 1 Nov 2018. The recall is Class II and its status is Terminated. Recall number Z-0220-2020.
Why was it recalled?
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.
Which lots are affected?
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
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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