FDA-Device2026-05-20Class IMISBRANDING
Omnicell i.v.Station label stock recalled for mislabeling risk in IV syringes
What this means
Certain rolls of label stock used in Omnicell i.v.Station devices may produce mislabeled syringes during IV medication preparation. The i.v.Station is a pharmacy automation device that compounds IV medications and applies identification labels. Mislabeled syringes could lead to medication identification errors.
- Check if your facility uses Omnicell i.v.Station with Part Numbers 258920028 (Lot QN 200023473) or 258900029 (Lot QN 200023474).
- Verify that syringes labeled by affected devices are correctly labeled before dispensing.
- Contact Omnicell for replacement label stock and instructions.
The agency's original wording
Hazard
Potential for mislabeled syringe produced by the i.v.STATION device.
Intended for
Adults
Illnesses reported
None reported
Sold states
US Distribution in Alabama, Maryland and Pennsylvania.
Affected count
220 units
Manufactured in
500 Cranberry Woods Dr Ste 400, Cranberry Township, PA, United States
Products
Rolls 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 and compounding of IV medications, which also applies labels to compounded preparations for identification and traceability.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2047-2026Want us to check the next one for you?
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