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U.S. Department of Health and Human Services

Class 2 Device Recall Ivenix Infusion System (IIS), LVP Software; LVPSW0004

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 Class 2 Device Recall Ivenix Infusion System (IIS), LVP Software; LVPSW0004see related information
Date Initiated by FirmApril 22, 2022
Date PostedSeptember 25, 2023
Recall Status1 Open3, Classified
Recall NumberZ-2635-2023
Recall Event ID 92973
510(K)NumberK183311 
Product Classification Pump, infusion - Product Code FRN
ProductIvenix Infusion System (IIS), Large Volume Pump (LVP) Software: 5.0.0 and 5.0.1 Part Number: LVP-SW-0004. Indicated for use in a hospital and in outpatient care environments for the controlled administration of fluids through clinically accepted routes of administration.
Code Information (UDI): 00811505030122 Software Version: 5.0.0 and 5.0.1
Recalling Firm/
Manufacturer		 Fresenius Kabi USA, LLC
50 High St Ste 50
North Andover MA 01845-2620
For Additional Information ContactMatt Kuhn
978-775-8050
Manufacturer Reason
for Recall		Start-up time for the flow rate range greater than 50 ml/hr, and less than 200 ml/hr may exceed the specified 6 minutes, depending on the characteristics of air bubble entrapment within the Intermediate Pumping Chamber (IPC) of the administration set
FDA Determined
Cause 2		Device Design
ActionIvenix initiated contact on 4/22/22/ via phone communicating the contents of the customer letter which was then emailed to each customer. Letter states reason for recall, health risk and action to take: Please note, the specified start-up flow accuracy of up to +8% is maintained throughout the extended start-up time; and the steady-state flow accuracy of +l-SYo of the LVP is not affected with this condition. There is no corrective action you need to take at this time. We believe that this condition is low risk in that the affected flow rate range is limited, the start'up flow rate accuracy is unaffected and still within specifications, and the clinical practice of monitoring patients while administering high alert drugs mitigates the risk. Ivenix is working on a software update to correct this condition. It will be available in approximately 60 days. We will inform you when that update is ready to install. If you have additional questions, please contact your Ivenix representative or support below. Customer support - email Customer support - phone suplrort@ivenix.com I-978-775-8TAA
Quantity in Commerce1344 pumps
DistributionUS Nationwide distribution in the states of NJ, WI.
Total Product Life CycleTPLC 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = FRN
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