Fresenius Kabi IV Administration Sets Recalled for Uncontrolled Medication Flow Risk
Fresenius Kabi is recalling LVP Primary Administration Sets due to a defect that may cause uncontrolled medication flow and potential overdose. The recall affects 4,500 pieces distributed in Colorado, Idaho, New Jersey, and Utah.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I designation establishes a minimum severity score of 4 for this medical device recall. The defect in an intravenous administration set poses a realistic risk of medication overdose, a serious health hazard, even though no illnesses have been reported.
Plain-English summary
Fresenius Kabi USA, LLC is recalling the LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Product Code: SET-0013-25) used for intravenous infusion. The recall involves 180 cases containing 4,500 units total. A defect in the product may cause uncontrolled medication flow, potentially resulting in doses greater than prescribed.
The affected lots have been distributed to healthcare facilities in Colorado, Idaho, New Jersey, and Utah. The specific lot number is 3010538, identified by UDI-DI: 00811505030054.
Patients and healthcare providers should not use the recalled units. Facilities that received this product should identify and quarantine the recalled sets, and contact Fresenius Kabi directly for return instructions. Healthcare providers should monitor patients who may have received infusions using the potentially affected equipment.
The recalled product
- Product
- LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty 25), Product Code: SET-0013-25. for intravenous infusion.
- Manufacturer
- Fresenius Kabi USA, LLC
- Hazard
- medication-overdose
- uncontrolled-medication-flow
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Product Code: SET-0013-25
- UDI-DI: 00811505030054
- Lot number: 3010538.
Distribution
Distributed in 4 states:
- CO
- ID
- NJ
- UT
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