LVP Software of the Ivenix Infusion System (IIS), Version 5.8.0.
Summary
The FDA issued a Class I for LVP Software of the Ivenix Infusion System (IIS), Version 5.8.0. by Fresenius Kabi USA, LLC. Reason: Software has anomalies that have the potential to cause underdose, overdose, or delay in therapy which could lead to serious patient harm or death..
Details
Source
Device Recall
External ID
Z-1484-2024
Action Date
2024-04-17
Status
Ongoing
Category
device
Product Description
LVP Software of the Ivenix Infusion System (IIS), Version 5.8.0.
Lot/Code Info: Product LVP-SW-0004; UDI-DI 00811505030122.
Quantity Affected: 17 units
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.
Distribution
US Distribution: CA, CO, ID, MI, NE, NJ, NV, OK, TX, UT, VA, WA, & WI.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-03-07
Company
North Andover, MA
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 171 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Fresenius Kabi USA, LLC has 46 FDA actions in our database, including 46 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Fresenius Kabi USA, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Fresenius Kabi USA, LLC have FDA actions?
Fresenius Kabi USA, LLC has 46 FDA actions in our database, including 46 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1484-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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