Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

i.v. Station and i.v. Station ONCO Automated Drug Compounding System, Pharmacy Compounding System Device Listing Number E454448

FDA Recall Z-0989-2017 · Posted 2017-01-10

Recalling FirmHEALTH ROBOTICS S.R.L.
Recall StatusTerminated
Product CodeNEP
Date Initiated2016-11-23
Date Terminated2017-03-15
Product Quantity121 systems

Reason for Recall

The firm has initiated a product correction due to a bag carousel motor error causing misalignment and resulting in a mislabeling of final IV bag preparations.

Firm Action

Omincell mailed an Urgent Medical Device Field Correction Notification letter to affected customers on 11/21/2016. The letter provided information of the event and instructions on how to continue operating the device to prevent risks. The issue will be corrected with a software update.

Root Cause

Software design

Distribution Pattern

Shipped throughout United States.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑