Severity
Moderate
ModerateClass IICompleted
FDA Devices recall · Reported March 20, 2024
LVP software of the Ivenix Infusion System (IIS), LVP-SW-0004
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, re…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Fresenius Kabi USA, LLC recalled LVP software of the Ivenix Infusion System (IIS), LVP-SW-0004 - a moderate-severity action.
LVP software of the Ivenix Infusion System (IIS), LVP-SW-0004 was recalled by Fresenius Kabi USA, LLC in March 20, 2024. Reason: Retroactively reported correction from 2022: A software defect may cause an incorrect (Fail-Stop) Alarm when …. Check the official notice for the remedy. Verify recall #Z-1282-2024 with the FDA Devices before acting.
The recall
Fresenius Kabi USA, LLC issued this moderate-severity FDA Devices recall-Retroactively reported correction from 2022: A software defect may cause an incorrect (Fail-Stop) Alarm when ….
- Moderate
- severity level
- 3 units
- affected scope
- Class II
- classification
- March 20, 2024
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1282-2024 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1282-2024) was formally reported on March 20, 2024, with the manufacturer initiating the action on September 16, 2022. It is classified under Moderate severity (Class II), with a current status of Completed. Fresenius Kabi USA, LLC is listed as the recalling firm, operating out of North Andover, MA. Federal records list the affected scope as 3.
The documented reason for this recall is: 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)… Distribution data in the federal record shows the product reached: US Nationwide distribution in the states of WI and NJ.. 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 moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
3
Related Recalls
6
3 from same agency
Product description
LVP software of the Ivenix Infusion System (IIS), LVP-SW-0004
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Completed |
| Recall number | Z-1282-2024 |
| Date reported | March 20, 2024 |
| Date initiated | September 16, 2022 |
| Recalling firm | Fresenius Kabi USA, LLC |
| Firm location | North Andover, MA |
| Affected scope | 3 |
| Distribution | US Nationwide distribution in the states of WI and NJ. |
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-1282-2024) 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.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. 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? ▼
LVP software of the Ivenix Infusion System (IIS), LVP-SW-0004. Recalled by Fresenius Kabi USA, LLC. Units affected: 3.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 20, 2024. Severity: Moderate. Recall number: Z-1282-2024.
Where was the recalled product distributed? ▼
Distribution: US Nationwide distribution in the states of WI and NJ..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1282-2024) 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 March 20, 2024. 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.