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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 93958

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
September 16, 2022
Product types
Device
Classifications
Class II
Statuses
Completed
Recalling firm wording
Fresenius Kabi USA, LLC

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

LVP software of the Ivenix Infusion System (IIS), LVP-SW-0004

Z-1282-2024
Recall number
Z-1282-2024
Initiated
September 16, 2022
Classification
Class II
Status
Completed
Recalling firm
Fresenius Kabi USA, LLC
Quantity
3

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
software defect may cause an incorrect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

UDI-DI 00811505030122 Software versions 5.0.1 and earlier.

Distribution pattern

US Nationwide distribution in the states of WI and NJ.