Device recall
Z-2065-2019: Vigilant Agilia, Vigilant Drug'Lib, REF Z073476, versions 1.0 and 1.1 Product…
FDA device recall · Class I · Fenwal Inc
Key facts
| Recall number (Z-number) | Z-2065-2019 |
|---|---|
| Recall event | 83138 |
| Product | Vigilant Agilia, Vigilant Drug'Lib, REF Z073476, versions 1.0 and 1.1 Product Usage: Vigilant Drug Lib is Dose Error Reduction Software that, when used in combination with Volumat MC Agilia infusion pumps, is intended to reduce drug administration errors at the bedside. Vigilant Drug Lib Agilia is a… |
| Product code | PHC |
| Recalling firm | Fenwal Inc |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Mar 6, 2023 |
| FEI number | 3004548776 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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