Exact FDA event identifier

Event 94228

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

Open FDA event record

Event summary

Timeline bucket: March 07, 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

LVP Software of the Ivenix Infusion System (IIS), Version 5.8.0.

Z-1484-2024

Recall number: Z-1484-2024
Initiated: March 07, 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 Change

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Software has anomalies that have the potential to cause underdose, overdose, or delay in therapy which could lead to serious patient harm or death.

Code information

Product LVP-SW-0004; UDI-DI 00811505030122.

Distribution pattern

US Distribution: CA, CO, ID, MI, NE, NJ, NV, OK, TX, UT, VA, WA, & WI.