Device recall
Z-1532-2025: IVX Station Reconstitution Transfer Set. Model Number: 298921215. Packaging: 1…
FDA device recall · Class II · Omnicell, Inc.
Key facts
| Recall number (Z-number) | Z-1532-2025 |
|---|---|
| Recall event | 96422 |
| Product | IVX Station Reconstitution Transfer Set. Model Number: 298921215. Packaging: 1 set per White Tyvek Pouch, 5 Tyvek Pouches per shelf box, 10 shelf boxes per case box. IVX Station Reconstitution Transfer Set is used for the reconstitution of drug vials in hospital pharmacies. It is indicated for use… |
| Product code | LHI |
| Recalling firm | Omnicell, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K212530 |
| FEI number | 3007880912 |
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