Exact FDA event identifier

Event 97554

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

Open FDA event record

Event summary

Timeline bucket: September 03, 2025
Product types: Device
Classifications: Class II
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), Large Volume Pump. Model Number: LVP-0004.

Z-0378-2026

Recall number: Z-0378-2026
Initiated: September 03, 2025
Classification: Class II
Status: Ongoing
Recalling firm: Fresenius Kabi USA, LLC
Quantity: 6 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Potential issue that can cause the device to register "phantom" touches in the lower-left corner of the touchscreen during operation.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential issue that can cause the device to register "phantom" touches in the lower-left corner of the touchscreen during operation.

Code information

Model Number: LVP-0004. UDI-DI: 00811505030320. Serial Numbers: 2318600378, 2321600176, 2333300359, 2403001383, 9242756430, 9243097443.

Distribution pattern

US Nationwide distribution in the state of Minnesota.