Reported Apr 16, 2025 · Ongoing
IVX Station Reconstitution Transfer Set. Model Number: 298921215. Packaging: 1 set per White Tyvek Pouch, 5 Tyvek…
Omnicell, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Omnicell, Inc. · 500 Cranberry Woods Dr Ste 400 · Cranberry Township, PA · 16066-5224
Is this the product you have?
- IVX Station Reconstitution Transfer Set
- Model Number298921215
- Packaging1 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. It is indicated for use with the IVX Station Pharmacy Compounding System
- Lot codes and dates
- Model number298921215
- UDI Number0086000726042101124301840119041525, 0086000726042101124300840119041525, 0086000726042101124301680119041525. Lot number 011243
- Amount recalled
- 3
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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