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U.S. Department of Health and Human Services

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

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  Class 2 Device Recall Ivenix Infusion System (IIS), LVP Software see related information
Date Initiated by Firm September 16, 2022
Date Posted March 11, 2024
Recall Status1 Completed
Recall Number Z-1282-2024
Recall Event ID 93958
510(K)Number K183311  
Product Classification Pump, infusion - Product Code FRN
Product LVP software of the Ivenix Infusion System (IIS), LVP-SW-0004
Code Information UDI-DI 00811505030122 Software versions 5.0.1 and earlier.
Recalling Firm/
Fresenius Kabi USA, LLC
50 High St Ste 50
North Andover MA 01845-2620
For Additional Information Contact Rebecca McCandless
Manufacturer Reason
for Recall
Retroactively reported correction from 2022: A software defect may cause an incorrect (Fail-Stop) Alarm when an administration set is loaded with an upstream occlusion present, resulting in a non-recoverable (Fail-Stop) Pump Problem alarm. This may lead to delay of therapy, and patient may experience from no to minimal to serious harm. This issue was resolved in all fielded product in software version 5.2.1, which was installed in September 2022.
FDA Determined
Cause 2
Software design
Action The issue was resolved through an update of the software to Version 5.2.1, which was installed at customer sites in September 2022. The firm did not issue a customer letter at the time. According to the firm, this issue has been resolved in all fielded product. There have been two subsequent software upgrades since Version 5.2.1 was released. Consignees are now on v 5.8.0.
Quantity in Commerce 3
Distribution US Nationwide distribution in the states of WI and NJ.
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.
510(K) Database 510(K)s with Product Code = FRN and Original Applicant = Ivenix, Inc.