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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 95240

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

Open FDA event record

Event summary

Timeline bucket
August 30, 2024
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-0004, Software Version 5.9.1 and prior. Infusion pump software for infusion management system.

Z-3153-2024
Recall number
Z-3153-2024
Initiated
August 30, 2024
Classification
Class I
Status
Ongoing
Recalling firm
Fresenius Kabi USA, LLC
Quantity
17 units

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
software has anomalies

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

The software has anomalies that have the potential to cause alarms, nonfunctioning pump, or unresponsive screen while continuing therapy. These could cause serious patient harm or death.

Code information

UDI-DI: 00811505030122; Software Version 5.9.1 and prior

Distribution pattern

US Nationwide.

Field note

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