Exact FDA event identifier

Event 97941

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

Open FDA event record

Event summary

Timeline bucket: November 03, 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, LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site (Qty 25). Large Volume Infusion Pump Administration Set.

Z-0586-2026

Recall number: Z-0586-2026
Initiated: November 03, 2025
Classification: Class I
Status: Ongoing
Recalling firm: Fresenius Kabi USA, LLC
Quantity: 483 cases (12,075 eaches)

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

Incorrect assembly

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Incorrect assembly of specific lot of LVP Primary Administration Set that could result in serious patient injury.

Code information

Product Code: SET-0032-25; UDI: 00811505030214; Lot No. FA25B03126.

Distribution pattern

US Nationwide distribution in the states of IL, MD, MI, OK, SC, TX, VA & WI.