Device recall
Z-1099-2019: SORIN Heater-Cooler System 3T, REF 16-02-85 Intended for use with a…
FDA device recall · Class II · LivaNova USA Inc.
Key facts
| Recall number (Z-number) | Z-1099-2019 |
|---|---|
| Recall event | 82365 |
| 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. |
| Product code | DWC |
| Recalling firm | LivaNova USA Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 14, 2022 |
| 510(k) numbers | K052601 |
| FEI number | 1718850 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database