Omnicell, Inc.: Rolls of label stock used with the Omnicell i.v.Station. 1. Part Number 258920028, LABEL, STERILE, IVSTATION SYRINGE (40MMX40MM).
Read the official notice at FDA (device) →
The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- Omnicell, Inc.
- Product
- 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.
- Reason / hazard
- Potential for mislabeled syringe produced by the i.v.STATION device.
- Classification
- Class I
- Status
- Ongoing
- Distribution / sold at
- US Distribution in Alabama, Maryland and Pennsylvania.
- Recall initiated
- 2026-03-25
- Code info
- 1. Part Number 258920028, Lot Number: QN 200023473. 2. Part Number 258900029, Lot Number: QN 200023474.
- Product quantity
- 220 units
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Cranberry Township
- State
- PA
- Country
- United States
- Event id
- 98717
Free daily digest + "My products" watchlist