Device 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.
Z-2047-2026
Product summary
- Firm
- Omnicell, Inc.
- Event
- Event 98717
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 220 units
- Official record key
device-enforcement:Z-2047-2026
Official wording
Reason: Potential for mislabeled syringe produced by the i.v.STATION device.
Code information: 1. Part Number 258920028, Lot Number: QN 200023473. 2. Part Number 258900029, Lot Number: QN 200023474.
Distribution pattern: US Distribution in Alabama, Maryland and Pennsylvania.
Derived failure modes
-
Labeling or packaging
mislabeled