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.
This recall is currently active, issued April 4, 2025. It was issued by Omnicell, Inc..
- Company
- Omnicell, Inc.
- Recall Initiated
- February 20, 2025
- Posted
- April 4, 2025
- Recall Number
- Z-1532-2025
- Quantity
- 3
- Firm Location
- Cranberry Township, PA
- Official Source
- View on FDA website ↗
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.
Distribution
Distributed in the US to Alabama
Lot / Code Info
Model number: 298921215. UDI Number: 0086000726042101124301840119041525, 0086000726042101124300840119041525, 0086000726042101124301680119041525. Lot number 011243.
Root Cause
Process control
Action Taken
Single customer was notified on 02/21/2025 via email and later received the letter via hand delivery on 02/25/2025. The notification instructed the customer that Omnicell personnel will remove the affected units, and any Reconstitution Transfer Sets required for Omnicell use during set up and upgrade will be provided as part of a supply kit and will be marked not for human use. The customer was requested to complete and return the Customer Acknowledgement and Receipt.