FDA Device recall Z-1532-2025
IVX Station Reconstitution Transfer Set
- FDA Device
- Class II
- ongoing
- Published 2025-04-16
On 2025-04-16 the FDA classified a Class II recall of IVX Station Reconstitution Transfer Set by Omnicell, citing IVX Station Reconstitution Transfer Sets were shipped in advance of the IVX Station upgrade and not intended for clinical use but are engineering devices intended for use during s….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1532-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-02-20 |
| Published | 2025-04-16 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Omnicell |
| Distribution | AL |
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 with the IVX Station Pharmacy Compounding System.
Reason
IVX Station Reconstitution Transfer Sets were shipped in advance of the IVX Station upgrade and not intended for clinical use but are engineering devices intended for use during set up and system calibration. The items were not shipped in a validated packing configuration and sterility cannot be ensured.
Identifiers
| code_info | Model number: 298921215. UDI Number: 0086000726042101124301840119041525, 0086000726042101124300840119041525, 008600072…Model number: 298921215. UDI Number: 0086000726042101124301840119041525, 0086000726042101124300840119041525, 0086000726042101124301680119041525. Lot number 011243. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1532-2025%22
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