Device recall
Z-1376-2022: ABACUS TPN (Total Parenteral Nutrition) Calculation software, Product codes…
FDA device recall · Class I · Baxter Healthcare Corporation
Key facts
| Recall number (Z-number) | Z-1376-2022 |
|---|---|
| Recall event | 90212 |
| Product | ABACUS TPN (Total Parenteral Nutrition) Calculation software, Product codes: 8300-0167 (Abacus V3.1 CE), 8300-0168 (Abacus V3.1 SE), 8300-0169 (Abacus V3.1 ME), 8300-0191 (Abacus V3.2 CE), 8300-0192 (Abacus V3.2 SE), 8300-0193 (Abacus V3.2 ME), 8300-3391 (Abacus V3.3 CE), 8300-3392 (Abacus V3.3 SE)… |
| Product code | NEP |
| Recalling firm | Baxter Healthcare Corporation |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Oct 9, 2024 |
| FEI number | 1417572 |
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