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U.S. Department of Health and Human Services

Class 1 Device Recall Ivenix Infusion Pump LVP Software

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  Class 1 Device Recall Ivenix Infusion Pump LVP Software see related information
Date Initiated by Firm March 07, 2024
Date Posted April 11, 2024
Recall Status1 Open3, Classified
Recall Number Z-1484-2024
Recall Event ID 94228
510(K)Number K183311  
Product Classification Pump, infusion - Product Code FRN
Product LVP Software of the Ivenix Infusion System (IIS), Version 5.8.0.
Code Information Product LVP-SW-0004; UDI-DI 00811505030122.
Recalling Firm/
Manufacturer		 Fresenius Kabi USA, LLC
50 High St Ste 50
North Andover MA 01845-2620
For Additional Information Contact Rebecca McCandless
847-550-2913
Manufacturer Reason
for Recall		 Software has anomalies that have the potential to cause underdose, overdose, or delay in therapy which could lead to serious patient harm or death.
FDA Determined
Cause 2		 Software Design Change
Action A letter titled URGENT - Medical Device Field Correction, dated 3/7/24, was delivered by hand to consignees or by mail notifying them of this recall event. This notice details eleven software anomalies that could pose a potential risk of serious patient harm or death and the mitigations consignees should perform until software is updated. Consignees are to update their software to LVP software version 5.9.1 by reaching out to their Fresenius Kabi representative at 1-978-775-8100 to schedule installation. Consignees are to complete and return the Customer Reply Form via fax or email. Questions about the recall notice can be directed to Fresenius Kabi by email at Ivenix_support@fresenius-kabi.com or by phone at 1-978-775-8100 (Monday through Friday from 8:30 am to 5:00 pm).
Quantity in Commerce 17 units
Distribution US Distribution: CA, CO, ID, MI, NE, NJ, NV, OK, TX, UT, VA, WA, & WI.
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 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) Database 510(K)s with Product Code = FRN and Original Applicant = Ivenix, Inc.
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