Device recall
Z-1566-2014: ABACUS TPN Calculation Software, Product Codes: 8300-0045 ABACUS CE (Calculator…
FDA device recall · Class I · Baxter Corporation Englewood
Key facts
| Recall number (Z-number) | Z-1566-2014 |
|---|---|
| Recall event | 67884 |
| Product | ABACUS TPN Calculation Software, Product Codes: 8300-0045 ABACUS CE (Calculator Edition), 8300-0046 ABACUS SE (Single-Workstation Edition), 8300-0047 ABACUS ME (Multi-Workstation Edition), 8300-0156 ABACUS 3.0 CE, 8300-0157 ABACUS 3.0 SE, 8300-0158 ABACUS 3.0 ME, 8300-0166 ABACUS 3.1 DE, 8300-0167… |
| Product code | NEP |
| Recalling firm | Baxter Corporation Englewood |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Jan 20, 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