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Omnicell, Inc.: Rolls of label stock used with the Omnicell i.v.Station. 1. Part Number 258920028, LABEL, STERILE, IVSTATION SYRINGE (40MMX40MM).

Medical DevicesSource: FDA (device) · Date: 2026-05-20

Read the official notice at FDA (device) →

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Omnicell, Inc.
Product
Rolls of label stock used with the Omnicell i.v.Station. 1. Part Number 258920028, LABEL, STERILE, IVSTATION SYRINGE (40MMX40MM). 2. Part Number 258900029, LABEL, STERILE, IVSTATION SYRINGE (20MMX40MM). Model/Catalog Number: IVS-RBT-001. i.v.STATION is an automation device used for preparation and compounding of IV medications, which also applies labels to compounded preparations for identification and traceability.
Reason / hazard
Potential for mislabeled syringe produced by the i.v.STATION device.
Classification
Class I
Status
Ongoing
Distribution / sold at
US Distribution in Alabama, Maryland and Pennsylvania.
Recall initiated
2026-03-25
Code info
1. Part Number 258920028, Lot Number: QN 200023473. 2. Part Number 258900029, Lot Number: QN 200023474.
Product quantity
220 units
Voluntary mandated
Voluntary: Firm initiated
City
Cranberry Township
State
PA
Country
United States
Event id
98717
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