Product Wiki · Recalls · U.S. FDA — Device Enforcement

Omnicell IVX Station-For use in the automated preparation of pharmaceutical admixtures and syringes Model Number: 298921373 — recall Z-1617-2023

U.S. FDA — Device Enforcement · United States · 2023-03-27 · Class II

Compiled from an official source — the facts on this page are reproduced from the issuing authority’s own published notice, which is linked above. No AI-generated text appears on this page. How we use AI →
Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1617-2023
Date of alert
2023-03-27
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
OmniCell, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00860006285005
Reported risk: IVX Station does not account for inherent scale inaccuracy or variability, could result in a preparation being passed that is outside of the dose accuracy stated in the product labeling
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.