Omnicell, Inc.: Device Recall
Recall #Z-1532-2025 · 02/20/2025
Class II: Risk
Recall Details
- Recall Number
- Z-1532-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Omnicell, Inc.
- Status
- Ongoing
- Date Initiated
- 02/20/2025
- Location
- Cranberry Township, PA, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3
Reason for Recall
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.
Product Description
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.
Distribution Pattern
Distributed in the US to Alabama
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.