Device recall
Z-0482-2025: Allegedly counterfeit batteries manufactured by CSB batteries being used with…
FDA device recall · Class I · ICU Medical, Inc.
Key facts
| Recall number (Z-number) | Z-0482-2025 |
|---|---|
| Recall event | 95586 |
| Product | Allegedly counterfeit batteries manufactured by CSB batteries being used with Plum Infusion Systems: Plum 360" Infusion System, Pump List Number 30010; Plum A+ & Plum A+3" Infusion Systems, Pump List Numbers: 11005, 11971, 12391, 12618, 20678, 20679, 20792, 60529, 12348, 1197 |
| Product code | FRN |
| Recalling firm | ICU Medical, Inc. |
| Recall class | Class I |
| Status | Open, Classified |
| FEI number | 3013319212 |
At a glance
- None 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