Device recall
Z-2140-2012: AUTOMIX Plus High Speed Compounder System, product 2M8075; automated nutrition…
FDA device recall · Class I · Baxter Healthcare Corp.
Key facts
| Recall number (Z-number) | Z-2140-2012 |
|---|---|
| Recall event | 62558 |
| Product | AUTOMIX Plus High Speed Compounder System, product 2M8075; automated nutrition compounders; Product Usage: The Automix Compounder Systems are electromechanical positive displacement fluid compounding devices used in the admixture of large volume parenteral nutrition formulations via gravimetric… |
| Product code | NEP |
| Recalling firm | Baxter Healthcare Corp. |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Aug 11, 2017 |
| FEI number | 1416980 |
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