Severity
Critical
CriticalClass IOngoing
FDA Devices recall · Reported February 12, 2025
Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Indicated for use in a hospital and in outpatient care environments for the controlled administration of fluids through clinically accepted routes of administration.
Large Volume Pump Software, version 5.9.2 and earlier has potential for the following anomalies: 1. The pump may become nonfunctional if during an alarm condition the Pause Audi…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Fresenius Kabi USA, LLC recalled Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Indicated for use in a hospita… - a critical-severity action.
Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Indicated for use in a hospita… was recalled by Fresenius Kabi USA, LLC in February 12, 2025. Reason: Large Volume Pump Software, version 5.9.2 and earlier has potential for the following anomalies: 1. The pum…. Check the official notice for the remedy. Verify recall #Z-1019-2025 with the FDA Devices before acting.
The recall
Fresenius Kabi USA, LLC issued this critical-severity FDA Devices recall-Large Volume Pump Software, version 5.9.2 and earlier has potential for the following anomalies: 1. The pum….
- Critical
- severity level
- Class I
- classification
- February 12, 2025
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1019-2025 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1019-2025) was formally reported on February 12, 2025, with the manufacturer initiating the action on January 10, 2025. It is classified under Critical severity (Class I), with a current status of Ongoing. Fresenius Kabi USA, LLC is listed as the recalling firm, operating out of North Andover, MA. Federal records list the affected scope as 23 systems.
The documented reason for this recall is: Large Volume Pump Software, version 5.9.2 and earlier has potential for the following anomalies: 1. The pump may become nonfunctional if during an alarm condition the Pause Audio option is repeated 70 time or more. … Distribution data in the federal record shows the product reached: US distribution to CA, CO, GA, ID, MI, MS, NE, NJ, NV, OK, TX, UT, VA, WA, WI.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
23 systems
Related Recalls
6
3 from same agency
Product description
Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Indicated for use in a hospital and in outpatient care environments for the controlled administration of fluids through clinically accepted routes of administration.
Reason for recall
Large Volume Pump Software, version 5.9.2 and earlier has potential for the following anomalies: 1. The pump may become nonfunctional if during an alarm condition the Pause Audio option is repeated 70 time or more. 2. If a secondary infusion is started at the exact moment a primary infusion completes and VTBI reaches 0, it will switch to primary. The primary infusion will infuse at the previously programed primary rate and continue until the infusion is stopped or the bag is empty.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Ongoing |
| Recall number | Z-1019-2025 |
| Date reported | February 12, 2025 |
| Date initiated | January 10, 2025 |
| Recalling firm | Fresenius Kabi USA, LLC |
| Firm location | North Andover, MA |
| Affected scope | 23 systems |
| Distribution | US distribution to CA, CO, GA, ID, MI, MS, NE, NJ, NV, OK, TX, UT, VA, WA, WI. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1019-2025) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Indicated for use in a hospital and in outpatient care environments for the controlled administration of fluids through clinically accepted routes of administration.. Recalled by Fresenius Kabi USA, LLC. Units affected: 23 systems.
Why was this product recalled? ▼
Large Volume Pump Software, version 5.9.2 and earlier has potential for the following anomalies: 1. The pump may become nonfunctional if during an alarm condition the Pause Audio option is repeated 70 time or more. 2. If a secondary infusion is started at the exact moment a primary infusion completes and VTBI reaches 0, it will switch to primary. The primary infusion will infuse at the previously programed primary rate and continue until the infusion is stopped or the bag is empty.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 12, 2025. Severity: Critical. Recall number: Z-1019-2025.
Where was the recalled product distributed? ▼
Distribution: US distribution to CA, CO, GA, ID, MI, MS, NE, NJ, NV, OK, TX, UT, VA, WA, WI..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1019-2025) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported February 12, 2025. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.