Device recall
Z-1628-2015: ABACUS SE (Single-Workstation Edition) and ABACUS ME (Multi-Workstation Edition)…
FDA device recall · Class II · Baxter Corporation Englewood
Key facts
| Recall number (Z-number) | Z-1628-2015 |
|---|---|
| Recall event | 70946 |
| Product | ABACUS SE (Single-Workstation Edition) and ABACUS ME (Multi-Workstation Edition) Product Usage: The ABACUS Software is a Windows-based order entry software application for comprehensive total parenteral nutrition (TPN) calculations and label printing. |
| Product code | NEP |
| Recalling firm | Baxter Corporation Englewood |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 1, 2016 |
| FEI number | 1419106 |
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