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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: 1. Part Number 258920028, Lot Number: QN 200023473. 2. Part Number 258900029, Lot Number: QN 200023474.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Omnicell, Inc.
- Reason for Recall:
- Potential for mislabeled syringe produced by the i.v.STATION device.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
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.
Product Codes/Lot Numbers:
1. Part Number 258920028, Lot Number: QN 200023473. 2. Part Number 258900029, Lot Number: QN 200023474.
Distribution:
Distributed in: US
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2047-2026
Related Recalls
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.
IVX Station does not account for inherent scale inaccuracy or variability, could result in a preparation being passed that is outside of the dose accuracy stated in the product labeling