FDA Device recall Z-0220-2020
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. ind…
- FDA Device
- Class II
- terminated
- Published 2019-11-06
On 2019-11-06 the FDA classified a Class II recall of 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. ind… by Livanova Usa, citing 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 ren….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0220-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-11-01 |
| Published | 2019-11-06 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Livanova Usa |
| Distribution | US |
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.
Reason
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.
Identifiers
| code_info | 16-02-80 Stockert Heater-Cooler System 3T, 230V, Serial #s 16S10027 thru 16S16874 16-02-81 Stockert Heater-Cooler Syst…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0220-2020%22
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