Recall Z-0220-2020 ยท DWC Controller, Temperature, Cardiopulmonary Bypass
LivaNova USA Inc.
SORIN Heater-Cooler System 3T 120V~/60Hz REF 16-02-85 Description of product: The Stckert 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 ox
| Date | Nov 1, 2018 |
| Status | Terminated |
| 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. |
| Root 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 |
| Quantity | 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, Denmar |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K052601 | STOCKERT HEATER-COOLER SYSTEM 3T Sorin Group Deutschland GmbH, Jun 6, 2006 |