Device recall
Z-1570-2022: The Exacta-Mix 2400 compounding system, manufactured by Baxter Healthcare…
FDA device recall · Class II · Baxter Healthcare Corporation
Key facts
| Recall number (Z-number) | Z-1570-2022 |
|---|---|
| Recall event | 90643 |
| Product | The Exacta-Mix 2400 compounding system, manufactured by Baxter Healthcare Corporation, is a compounding device used in the pharmacy to compound multiple source ingredients into one final solution. This device is not intended for direct patient hook-up. |
| Product code | LHI |
| Recalling firm | Baxter Healthcare Corporation |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K002705 |
| FEI number | 1417572 |
At a glance
- 1–9 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