FDA recall Z-1532-2025

Omnicell, Inc. · Class II · device

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 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

Key facts

Status
Ongoing
Initiation date
2025-02-20
Report date
2025-04-16
Voluntary/Mandated
Voluntary: Firm initiated
Location
Cranberry Township, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1532-2025