Device recall
Z-0362-2019: Volumat MC Agilia Volumetric Infusion Pump, Model No. Z021135, Software version…
FDA device recall · Class II · Fresenius Vial Sa
Key facts
| Recall number (Z-number) | Z-0362-2019 |
|---|---|
| Recall event | 81208 |
| Product | Volumat MC Agilia Volumetric Infusion Pump, Model No. Z021135, Software version 1.7. 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… |
| Product code | FRN |
| Recalling firm | Fresenius Vial Sa |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 11, 2021 |
| 510(k) numbers | K121613 |
| FEI number | 3000240707 |
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