FDA Device Recall Z-0586-2026

Fresenius Kabi USA, LLC · North Andover, MA

Class I — life-threatening Ongoing

Highest impact — Class I device recall — FDA determination that use of, or exposure to, the device will cause serious adverse health consequences or death. Distribution is nationwide and the recall remains in progress.

Device

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.

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

Quantity: 483 cases (12,075 eaches)

Reason for recall

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

Recall record

Recall number: Z-0586-2026
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: E-Mail
Distribution: US Nationwide distribution in the states of IL, MD, MI, OK, SC, TX, VA & WI.
Recall initiated: 2025-11-03
Classified by FDA Center: 2025-12-03
FDA published: 2025-12-10
Recalling firm: Fresenius Kabi USA, LLC
Firm location: North Andover, MA

Operational response

A Class I device recall indicates a strong likelihood of serious adverse health consequence or death from continued use. Identify affected units by serial number, lot, or GTIN against your inventory and against implanted-device patient registry. Pull affected inventory from active use immediately. For implanted devices, follow the recalling firm’s patient-notification protocol; in most cases this requires informing affected patients and their treating physicians directly.

For the official FDA enforcement record, see FDA's Recall Search.

‹ All device recalls