Device recall
Z-0832-2022: Nimbus PainPro Ambulatory Infusion Pumps with software version v4, Model Number…
FDA device recall · Class II · InfuTronix LLC
Key facts
| Recall number (Z-number) | Z-0832-2022 |
|---|---|
| Recall event | 89711 |
| Product | Nimbus PainPro Ambulatory Infusion Pumps with software version v4, Model Number IT1072, sold as kit IT1075-DUKE-HSP, IT1076-DUKE-HSP and IT1077-DUKE-HSP |
| Product code | FRN |
| Recalling firm | InfuTronix LLC |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | 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