Rolls of label stock used with the Omnicell i.v.Station. 1. Part Number 258...
Reason for Recall / Hazard
Potential for mislabeled syringe produced by the i.v.STATION device.
Product Description & Identification
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.
Affected 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.
Additional Source Details
| Field | Value |
|---|---|
| City | Cranberry Township |
| State | PA |
| Event id | 98717 |
| Address 1 | 500 Cranberry Woods Dr Ste 400 |
| Code info | 1. Part Number 258920028, Lot Number: QN 200023473. 2. Part Number 258900029, Lot Number: QN 200023474. |
| Postal code | 16066-5224 |
| Report date | 20260520 |
| Product type | Devices |
| Product quantity | 220 units |
| Reason for recall | Potential for mislabeled syringe produced by the i.v.STATION device. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260325 |
| Initial firm notification | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
| Center classification date | 20260513 |
Overview
- Recalling FirmOmnicell, Inc.
- StatusOngoing
- Risk LevelClass I
- DistributionUS Distribution in Alabama, Maryland and Pennsylvania.