Device recall
Z-2030-2012: SIGMASpectrum Infusion Pump Master Drug Library (MDL) Editor software. Product…
FDA device recall · Class III · Sigma
Key facts
| Recall number (Z-number) | Z-2030-2012 |
|---|---|
| Recall event | 61691 |
| Product | SIGMASpectrum Infusion Pump Master Drug Library (MDL) Editor software. Product Usage: A customized in-house library of all IV and epidural drugs, along with their safe delivery parameters. |
| Product code | FRN |
| Recalling firm | Sigma |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Jul 5, 2018 |
| 510(k) numbers | K042121 |
| FEI number | 1314492 |
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