Device recall
Z-0664-2018: Sorin Group Smart Perfusion Pack E-Pack, REF 088511400, Rev: L, Single Use…
FDA device recall · Class III · LivaNova USA
Key facts
| Recall number (Z-number) | Z-0664-2018 |
|---|---|
| Recall event | 79000 |
| Product | Sorin Group Smart Perfusion Pack E-Pack, REF 088511400, Rev: L, Single Use, Sterile, Rx. The firm name on the label is Sorin Group USA, Inc., Arvada, CO. |
| Product code | DWE |
| Recalling firm | LivaNova USA |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Aug 11, 2020 |
| 510(k) numbers | K981613 |
| 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