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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 96085

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

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Event summary

Timeline bucket
January 10, 2025
Product types
Device
Classifications
Class I
Statuses
Ongoing
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

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.

Z-1019-2025
Recall number
Z-1019-2025
Initiated
January 10, 2025
Classification
Class I
Status
Ongoing
Recalling firm
Fresenius Kabi USA, LLC
Quantity
23 systems

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
Software, version 5.9.2 and earlier has potential for the following anomalies

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software Design Change

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

UDI-DI: 00811505030122. Software 5.9.2 and prior

Distribution pattern

US distribution to CA, CO, GA, ID, MI, MS, NE, NJ, NV, OK, TX, UT, VA, WA, WI.