Device recall
Z-1285-2024: Nimbus Administration Set; Nimbus Flex; Nimbus PainPro (a.k.a. Halo Ambulatory…
FDA device recall · Class I · InfuTronix LLC
Key facts
| Recall number (Z-number) | Z-1285-2024 |
|---|---|
| Recall event | 94124 |
| Product | Nimbus Administration Set; Nimbus Flex; Nimbus PainPro (a.k.a. Halo Ambulatory Infusion System); Catalog Number IT1025. 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