Device recall
Z-2129-2025: Plum Duo Infusion System, List Number: 400020401
FDA device recall · Class I · ICU Medical, Inc.
Key facts
| Recall number (Z-number) | Z-2129-2025 |
|---|---|
| Recall event | 97186 |
| Product | Plum Duo Infusion System, List Number: 400020401 |
| Product code | FRN |
| Recalling firm | ICU Medical, Inc. |
| Recall class | Class I |
| Status | Open, Classified |
| 510(k) numbers | K223607 |
| 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