Omnicell IVX Station Reconstitution Transfer Sets recalled for sterility concerns
Omnicell has recalled 3 IVX Station Reconstitution Transfer Sets (Model 298921215) distributed in Alabama due to improper packing that prevents sterility assurance. The engineering devices were shipped for system setup, not clinical use.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall with no reported illnesses or injuries. The devices are engineering equipment shipped for system setup, not intended for clinical use, which reduces the actual hazard risk. The inability to ensure sterility represents a theoretical concern without documented adverse events.
Plain-English summary
The IVX Station Reconstitution Transfer Set, Model Number 298921215, is a component used in hospital pharmacies to reconstitute drug vials with the IVX Station Pharmacy Compounding System. Omnicell, Inc. has recalled 3 units that were distributed in Alabama.
The recalled units were shipped in advance of an IVX Station system upgrade as engineering devices intended for setup and system calibration, not for clinical use. These units were not shipped in a validated packing configuration, and sterility cannot be ensured.
Hospital pharmacies that may have received these devices should identify the affected units using lot number 011243, model number 298921215, and the UDI numbers provided in the recall notice. These devices should not be used to reconstitute drug vials. For questions or to report any concerns, facilities should contact Omnicell, Inc.
The recalled product
- Product
- IVX Station Reconstitution Transfer Set. Model Number: 298921215. Packaging: 1 set per White Tyvek Pouch, 5 Tyvek Pouches per shelf box, 10 shelf boxes per case box. IVX Station Reconstitution Transfer Set is used for the reconstitution of drug vials in hospital pharmacies. I
- Manufacturer
- Omnicell, Inc.
- Hazard
- sterility-compromise
- improper-packaging
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Model number: 298921215. UDI Number: 0086000726042101124301840119041525
- 0086000726042101124300840119041525
- 0086000726042101124301680119041525. Lot number 011243.
Distribution
Distribution scope not specified by the agency.
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