Omnicell IVX Station-For use in the automated preparation of pharmaceutical admixtures and syringes Model Number: 298921373
Class I - DangerousWhat Should You Do?
- Check if you have this product: UDI-DI: 00860006285005 Serial Numbers: IVXS000014, IVXS000015, IVXS000016, IVXS000017, IVXS000018. IVXS000019
- 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:
- 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
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Omnicell IVX Station-For use in the automated preparation of pharmaceutical admixtures and syringes Model Number: 298921373
Product Codes/Lot Numbers:
UDI-DI: 00860006285005 Serial Numbers: IVXS000014, IVXS000015, IVXS000016, IVXS000017, IVXS000018. IVXS000019
Distribution:
Distributed in: AL, NY
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1617-2023
Related Recalls
Potential for mislabeled syringe produced by the i.v.STATION device.
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.