Device recall
Z-1286-2024: Nimbus II Infusion System; Nimbus II PainPRO IT1053; Nimbus II Flex IT1062…
FDA device recall · Class I · InfuTronix LLC
Key facts
| Recall number (Z-number) | Z-1286-2024 |
|---|---|
| Recall event | 94124 |
| Product | Nimbus II Infusion System; Nimbus II PainPRO IT1053; Nimbus II Flex IT1062; Nimbus II Plus IT1078; Nimbus II EpiD IT1124; Nimbus II EMS IT1063; Ambulatory Infusion Pump and components |
| Product code | FRN |
| Recalling firm | InfuTronix LLC |
| Recall class | Class I |
| Status | Open, Classified |
| 510(k) numbers | K140783, K153193 |
| FEI number | 3011581906 |
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