Omnicell, Inc. recalls IVX Station Reconstitution Transfer Set. Model Number: 298921215. Packaging: 1 set per White Tyvek Pouch, 5 Tyvek Pouch…

Recall date

February 20, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1532-2025

FDA classification

Class II

Brand / firm

Omnicell, Inc.

Sold / distributed

Distributed in the US to Alabama

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.