Device recall
Z-2064-2019: VOLUMAT MC AGILIA US, Infusion Pump, REF Z021135, software versions 1.7 and 1.9a…
FDA device recall · Class I · Fenwal Inc
Key facts
| Recall number (Z-number) | Z-2064-2019 |
|---|---|
| Recall event | 83138 |
| Product | VOLUMAT MC AGILIA US, Infusion Pump, REF Z021135, software versions 1.7 and 1.9a Product Usage: The Volumat MC Agilia is a piece of transportable medical equipment intended to be used in healthcare facilities environment by healthcare trained professionals according to hospital protocols on adults… |
| Product code | FRN |
| Recalling firm | Fenwal Inc |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Mar 6, 2023 |
| 510(k) numbers | K121613 |
| FEI number | 3004548776 |
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