IVX Station Transfer Set (Omnicell) – Premature Deployment (2025)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Omnicell, Inc.
Lot Codes / Batch Numbers
Model number: 298921215. UDI Number: 0086000726042101124301840119041525, 0086000726042101124300840119041525, 0086000726042101124301680119041525. Lot number 011243.
Products Sold
Model number: 298921215. UDI Number: 0086000726042101124301840119041525, 0086000726042101124300840119041525, 0086000726042101124301680119041525. Lot number 011243.
Omnicell, Inc. is recalling IVX Station Reconstitution Transfer Set. Model Number: 298921215. Packaging: 1 set per White Tyvek P due to IVX Station Reconstitution Transfer Sets were shipped in advance of the IVX Station upgrade and not intended for clinical use but are engineering devi. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AL, IN
Page updated: Jan 10, 2026