Ivenix Infusion System recall
IVENIX INFUSION SYSTEM, LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site (Qty 25). Large Volume Infusion Pump…
Why was Ivenix Infusion System recalled?
Incorrect assembly of specific lot of LVP Primary Administration Set that could result in serious patient injury.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Product Code: SET-0032-25; UDI: 00811505030214; Lot No. FA25B03126.
- Product
- IVENIX INFUSION SYSTEM, LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site (Qty 25). Large Volume Infusion Pump…
- Recalling firm
- Fresenius Kabi USA, LLC
- Quantity
- 483 cases (12,075 eaches)
- Distribution
- US Nationwide distribution in the states of IL, MD, MI, OK, SC, TX, VA & WI.
- Recall date
- December 10, 2025
- Classification
- Class I
- Status
- Ongoing
- Agency
- FDA (device)