Class 2 Device Recall i.v. Station, i.v. Station ONCO

• Date Initiated by Firm: November 23, 2016
• Date Posted: January 10, 2017
• Recall Status: Terminated on March 15, 2017
• Recall Number: Z-0989-2017
• Recall Event ID: 76102
• Product Classification: System/device, pharmacy compounding - Product Code NEP
• Product: i.v. Station and i.v. Station ONCO Automated Drug Compounding System, Pharmacy Compounding System Device Listing Number E454448
• Code Information: All serial numbers are affected.
• FEI Number: 3006153342
• Recalling Firm/ Manufacturer: HEALTH ROBOTICS S.R.L.; Via Sebastian Altmann 9 A; 39100; Bolzano Italy
• Manufacturer 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.
• FDA Determined Cause: Software design
• 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.
• Quantity in Commerce: 121 systems
• Distribution: Shipped throughout United States.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 �7.55.