Device recall
Z-1963-2014: EXACTAMIX 1200 Compounder, model numbers 1200-DY, 1200-DX, 1200-DYR and…
FDA device recall · Class II · Baxter Healthcare Corp.
Key facts
| Recall number (Z-number) | Z-1963-2014 |
|---|---|
| Recall event | 68506 |
| Product | EXACTAMIX 1200 Compounder, model numbers 1200-DY, 1200-DX, 1200-DYR and 1200-DXR; EM1200 DY Display, Replacement EM 1200 DY Display. EXACTAMIX 2400 Compounder model numbers 2400-DY, 2400-DX, 2400-DYR and 2400-DYX. Baxa Corporation. An automated pumping system that compounds multiple sterile… |
| Product code | LHI |
| Recalling firm | Baxter Healthcare Corp. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 22, 2017 |
| 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