FDA Medical devices recall ·
IVENIX INFUSION SYSTEM, LVP Primary Administration Set, Dual-Inlet… recall
This is an FDA Class I recall — the most serious type.
- Recall number
- Z-0586-2026
- Date
- (initiated November 3, 2025)
- Company / brand
- Fresenius Kabi USA, LLC
50 High St Ste 50, North Andover, MA, United States - Category
- Medical devices › Class I
- Classification
- Class I
- Status
- Ongoing
- Units affected
- 483 cases (12,075 eaches)
- Hazard tags
- Injury risk
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
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.
Why was it recalled?
Incorrect assembly of specific lot of LVP Primary Administration Set that could result in serious patient injury.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Product Code: SET-0032-25; UDI: 00811505030214; Lot No. FA25B03126.
Distribution
US Nationwide distribution in the states of IL, MD, MI, OK, SC, TX, VA & WI.
States: Illinois Maryland Michigan Oklahoma South Carolina Texas Virginia Wisconsin
What does Class I mean?
Class I is the most serious FDA recall class: there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.
Source: FDA (medical devices), recall Z-0586-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.