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U.S. Department of Health and Human Services

Class 1 Device Recall Ivenix Infusion System (IIS)

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 Class 1 Device Recall Ivenix Infusion System (IIS)see related information
Date Initiated by FirmAugust 30, 2024
Date PostedSeptember 26, 2024
Recall Status1 Open3, Classified
Recall NumberZ-3153-2024
Recall Event ID 95240
510(K)NumberK183311 
Product Classification Pump, infusion - Product Code FRN
ProductIvenix Infusion System (IIS), LVP Software; LVP-SW-0004, Software Version 5.9.1 and prior. Infusion pump software for infusion management system.
Code Information UDI-DI: 00811505030122; Software Version 5.9.1 and prior
Recalling Firm/
Manufacturer		 Fresenius Kabi USA, LLC
50 High St Ste 50
North Andover MA 01845-2620
For Additional Information ContactRebecca McCandless
847-550-2913
Manufacturer Reason
for Recall		The software has anomalies that have the potential to cause alarms, nonfunctioning pump, or unresponsive screen while continuing therapy. These could cause serious patient harm or death.
FDA Determined
Cause 2		Software design
ActionAn URGENT Medical Device Field Correction Important Safety Update notification letter dated 8/30/24 was sent to customers. Required Actions for Users: 1. Please fill out the Customer Reply Form attached to this letter to acknowledge receipt. 2. If your facility further distributes or transfers products to satellite sites or other locations, please ask these locations to contact the email address on the Customer Reply Form so we can send notice to those satellites directly. 3. Install new software version (5.9.2) for the Ivenix Large Volume Pump (LVP). See details below. How To Obtain and Install Software Version 5.9.2 To request installation, please reach out promptly to your Fresenius Kabi representative (1-855- 354-6387 or Ivenix_support@fresenius-kabi.com). They will push the new software update to your pumps. When the LVP version 5.9.2 software update has been sent to the LVP, the following prompt appears before the LVP is shut down. Customer support - email Ivenix_su pport@fresenius-kabi.com Customer support - phone 1-855-354-6387 Normal business Hours are Monday through Friday 8:30 AM to 5 PM Eastern Time, After Hours Supported with Voicemail Messaging
Quantity in Commerce17 units
DistributionUS Nationwide.
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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