FDAFebruary 20, 2025device
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 us...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Ongoing
Brands named
omnicell
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDARolls of label stock used with the Omnicell i.v.Station. 1. Part Number 258920028, LABEL, STERILE, IVSTATION SYRINGE (40MMX40MM). 2. Part Number 258900029, LABEL, STERILE, IVSTATION SYRINGE (20MMX40MM). Model/Catalog Number: IVS-RBT-001. i.v.STATION is an automation device used for preparation an...2026-03-25
- FDAOmnicell IVX Station-For use in the automated preparation of pharmaceutical admixtures and syringes Model Number: 2989213732023-03-27
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