Device recall
Z-2055-2019: Nimbus Administration Set, REF HS-004, UDI # 00817170020031 Product Usage…
FDA device recall · Class II · InfuTronix LLC
Key facts
| Recall number (Z-number) | Z-2055-2019 |
|---|---|
| Recall event | 82997 |
| Product | Nimbus Administration Set, REF HS-004, UDI # 00817170020031 Product Usage: Administer fluids/medication from a container to a patient through a needle or a catheter. |
| Product code | FRN |
| Recalling firm | InfuTronix LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 22, 2020 |
| 510(k) numbers | K140792 |
| 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