Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 98929

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

Open FDA event record

Event summary

Timeline bucket
May 06, 2026
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

LVP software of the Ivenix Infusion System (IIS); Product Code LVP-SW-0005.

Z-2223-2026
Recall number
Z-2223-2026
Initiated
May 06, 2026
Classification
Class I
Status
Ongoing
Recalling firm
Fresenius Kabi USA, LLC
Quantity
32 systems

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
software anomaly

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design (manufacturing process)

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential software anomaly that can cause the pump to report a false battery-health value (typically 69%) and trigger a battery-depletion alarm that will shut down the pump unless it is reconnected to AC mains power.

Code information

Product Code LVP-SW-0005. UDI-DI: 00811505030122. Software Version 5.10.2

Distribution pattern

US Nationwide distribution in the states of CA, CO, FL, GA, GA, ID, IL, MD, MI, MN, MO, MS, NE, NJ, NV, OK, OR, SC, TX, VA, WA, WI.