Device recall
Z-0101-2018: Plum 360 Infusion System, List number 30010.
FDA device recall · Class II · ICU Medical Inc
Key facts
| Recall number (Z-number) | Z-0101-2018 |
|---|---|
| Recall event | 78312 |
| Product | Plum 360 Infusion System, List number 30010. |
| Product code | FRN |
| Recalling firm | ICU Medical Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 28, 2019 |
| 510(k) numbers | K161469 |
| FEI number | 3013319212 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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