Omnicell recalls IVX Station Reconstitution Transfer Sets (model 298921215) due to potential sterility issues from improper packaging. Affected units shipped before system upgrade may not be safe for clinical use.
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.
Omnicell is recalling IVX Station Reconstitution Transfer Sets (model 298921215) because they were shipped before the IVX Station upgrade and not designed for clinical use. This means the sets might not be sterile, posing a risk of infection if used in hospitals.
These transfer sets were not intended for clinical use and were shipped without proper packaging validation. This could lead to contamination or infection if the sets are used in hospital settings.
Hospital pharmacy staff and healthcare workers who use the IVX Station Pharmacy Compounding System are most at risk. Units shipped before the system upgrade are affected.
Check for model number 298921215 on the transfer set. The packaging includes 1 set per White Tyvek Pouch, 5 pouches per shelf box, and 10 boxes per case box. Units shipped before the IVX Station upgrade are affected.
Look for model number 298921215 on the transfer set packaging.
The IVX Station Reconstitution Transfer Sets were shipped before the IVX Station upgrade and not designed for clinical use, which means sterility cannot be ensured.
The recall does not specify a remedy, so contact Omnicell directly for guidance.
Yes, the sets may not be sterile, which could lead to infection if used in hospital settings.
We’ve drafted a message you can send Omnicell to request your refund or repair — edit it as you like.
Subject: Recall Z-1532-2025 — Omnicell Omnicell Hello, I own a Omnicell that is covered by recall Z-1532-2025 from Omnicell. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
