FDA Device recall Z-1099-2019
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…
- FDA Device
- Class II
- terminated
- Published 2019-04-17
On 2019-04-17 the FDA classified a Class II recall of 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… by Livanova Usa, citing for six units, the post-deep cleaning (DC) water sample tested positive for nontuberculous mycobacteria (NTM).
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1099-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-09-14 |
| Published | 2019-04-17 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Livanova Usa |
| Distribution | IN, MO, OH |
Product
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.
Reason
For six units, the post-deep cleaning (DC) water sample tested positive for nontuberculous mycobacteria (NTM).
Identifiers
| code_info | Serial numbers 16S13187, 16S14887, 16S15335, 16S15336, 16S15337, and 16S11877. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
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FDA Device · Class II · 2022-02-09 · Livanova Usa
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1099-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.