Device recall
Z-2448-2024: Replacement Battery List Number SUB0000594 and SUB0000864 found in Plum A+ &…
FDA device recall · Class I · ICU Medical Inc
Key facts
| Recall number (Z-number) | Z-2448-2024 |
|---|---|
| Recall event | 94690 |
| Product | Replacement Battery List Number SUB0000594 and SUB0000864 found in Plum A+ & Plum A+3 Infusion Systems, Pump List Numbers: 11005, 11971, 12391, 12618, 20678, 20679, 20792, 60529, 12348, 11973. OUS units marketed with the following descriptions: Plum A+ Mednet TM Firmware New 13.6 Span, Plum A+3… |
| Product code | FRN |
| Recalling firm | ICU Medical Inc |
| Recall class | Class I |
| Status | Open, Classified |
| 510(k) numbers | K042081, K070398 |
| 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