Omnicell, Inc. is recalling 3 units of its IVX Station Reconstitution Transfer Set (Model 298921215, Lot 011243). These sets were intended only as engineering devices for system setup and calibration and were not meant for clinical use. Because they were shipped in non-validated packaging, their sterility cannot be guaranteed, making them unsafe for patient care. No injuries or incidents have been reported to date.
The sterility of these sets cannot be ensured due to improper packaging configurations during shipment. If used for drug reconstitution in clinical settings, non-sterile sets could introduce bacterial or fungal contaminants into medications, potentially causing serious infections in patients.
Packaging: 1 set per White Tyvek Pouch, 5 Tyvek Pouches per shelf box, 10 shelf boxes per case box. Indicated for use with the IVX Station Pharmacy Compounding System.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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