Class I recallOngoing

IVENIX INFUSION SYSTEM, LVP Primary Administration Set, Dual-Inlet, recall — FDA event 97941

FDA · FDA event 97941 · Posted Dec 3, 2025

Published Dec 3, 2025Updated Oct 8, 2026Source last checked: 2026-10-08 16:03:16 UTC

What happened

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

Who may be affected

People using a product, model, software version, lot, or UDI listed in the affected-products table and official FDA record.
A mention of the device family does not mean every unit is affected. Compare the identifiers on your product with the official source.

What the official notice recommends

An URGENT - Voluntary Recall notice dated 10/30/25 was emailed to consignees. Consignees are instructed to discontinue use and distribution of affected devices immediately; check inventory and quarantine all affected devices. The recall notification is to be shared with users and inventory replaced with unaffected stock. Consignees with no affected devices are to complete and return the provided response form. Consignees with affected devices are to either destroy or return affected devices; replacements can be requested by contacting Fresenius Kabi Customer Service at 855-354-6387 (x1). If consignees destroy product, Fresenius Kabi will provide a Certificate of Destruction which must be completed and returned. Consignees with any questions are to email Ivenix_support@fresenius-kabi.com or call 855-354-6387.

The official notice takes precedence over this summary. Talk to your clinician before changing prescribed therapy.

Affected products and models

This FDA record lists IVENIX INFUSION SYSTEM, LVP Primary Administration Set, Dual-Inlet, by Fresenius Kabi USA, LLC.

Products affected by FDA event 97941
Model	Description	Lot / serial range	Manufactured	Status
Z-0586-2026	Z-0586-2026	Product Code: SET-0032-25; UDI: 00811505030214; Lot No. FA25B03126.	Not provided in the normalized record	Ongoing

Distribution: US Nationwide distribution in the states of IL, MD, MI, OK, SC, TX, VA & WI.
Units affected: See official FDA record
Category: Infusion pumps

Timeline

Nov 3, 2025
Recall initiated
Date recorded by the FDA.
Dec 3, 2025
Posted by FDA
The recall event appeared in the FDA source.
Oct 8, 2026
Last checked
MedWatcher last reconciled this record with the openFDA export.

Primary source

U.S. Food and Drug Administration

Identifier: 97941
Published: Dec 3, 2025
Source checked: 2026-10-08 16:03:16 UTC

Official openFDA device-recall record. The FDA source takes precedence over this normalized summary.

View official record

How MedWatcher checks these sources

Class II recallOngoing

ICU Medical Plum Duo Infusion Pump, v1 recall — FDA event 99192

In a specific scenario, the pump will not decrement the Volume to be Infused (VTBI) displayed on the Delivery screen and may deliver up to twice the VTBI at the programmed rate.

FDA · FDA event 99192Posted Jul 10, 2026

Class II recallCompleted

Intera Oncology INTERA 3000 Hepatic Artery Infusion Pump, AP-0300H, recall — FDA event 99063

There is the potential for leakage along the drug pathway from the pump through the end of the catheter.

FDA · FDA event 99063Posted Jun 25, 2026

Class II recallOngoing

Plum Duo Infusion Pump, 40002-0401 recall — FDA event 98872

Under certain conditions, the pump may not display a soft limit alert, and will not notify the clinician of a soft limit violation before confirming and starting delivery. This may potentially lead to under- or over-delivery.

FDA · FDA event 98872Posted Jun 5, 2026

Loading MedWatcher information…

IVENIX INFUSION SYSTEM, LVP Primary Administration Set, Dual-Inlet, recall — FDA event 97941

FDA · FDA event 97941 · Posted Dec 3, 2025

Published Dec 3, 2025Updated Oct 8, 2026Source last checked: 2026-10-08 16:03:16 UTC

Affected products and models

This FDA record lists IVENIX INFUSION SYSTEM, LVP Primary Administration Set, Dual-Inlet, by Fresenius Kabi USA, LLC.

Products affected by FDA event 97941
Model	Description	Lot / serial range	Manufactured	Status
Z-0586-2026	Z-0586-2026	Product Code: SET-0032-25; UDI: 00811505030214; Lot No. FA25B03126.	Not provided in the normalized record	Ongoing

Distribution

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

Units affected

See official FDA record

ICU Medical Plum Duo Infusion Pump, v1 recall — FDA event 99192

In a specific scenario, the pump will not decrement the Volume to be Infused (VTBI) displayed on the Delivery screen and may deliver up to twice the VTBI at the programmed rate.

FDA · FDA event 99192Posted Jul 10, 2026

Class II recallCompleted

Intera Oncology INTERA 3000 Hepatic Artery Infusion Pump, AP-0300H, recall — FDA event 99063

There is the potential for leakage along the drug pathway from the pump through the end of the catheter.

FDA · FDA event 99063Posted Jun 25, 2026

Class II recallOngoing

Plum Duo Infusion Pump, 40002-0401 recall — FDA event 98872

FDA · FDA event 98872Posted Jun 5, 2026

IVENIX INFUSION SYSTEM, LVP Primary Administration Set, Dual-Inlet, recall — FDA event 97941

Follow IVENIX INFUSION SYSTEM, LVP Primary Administration Set, Dual-Inlet,

What happened

Who may be affected

What the official notice recommends

Affected products and models

Timeline

IVENIX INFUSION SYSTEM, LVP Primary Administration Set, Dual-Inlet, recall — FDA event 97941

Follow IVENIX INFUSION SYSTEM, LVP Primary Administration Set, Dual-Inlet,

What happened

Who may be affected

What the official notice recommends

Affected products and models

Timeline

What happened

Who may be affected

What to do

What the official notice recommends

Affected products and models

Timeline

What happened

Who may be affected

What to do

What the official notice recommends

Affected products and models

Timeline