Recall Z-1099-2019 ยท DWC Controller, Temperature, Cardiopulmonary Bypass
LivaNova USA Inc.
SORIN Heater-Cooler System 3T, REF 16-02-85 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.
| Date | Sep 14, 2018 |
| Status | Terminated |
| Reason | For six units, the post-deep cleaning (DC) water sample tested positive for nontuberculous mycobacteria (NTM). |
| Root cause | Material/Component Contamination |
| Action | The recalling firm, LivaLova, contacted the first customer by phone on 9/14/2018 followed by an "IMPORT" letter, the first of which was dated 9/18/2018. The letter described the product, problem and actions to be taken. The customers were instructed to do the following: keep these devices out of service until the investigation is complete. To return your device, please email 3T.US@livanova.com. If taking Serial Numbers 16S15335 and 16S15337 out of service will negatively impact your clinical practice, we can arrange for delivery of loaner devices during this investigation and,as necessary, wh |
| Quantity | 6 devices |
| Distribution | US Distribution to states of: IN, MO, and OH. |
| 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 |