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FDAFDA · Food and drugs·Recall number Z-2721-2024

LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty 25), Product Code: SET-0013-25. for intravenous infusion.

Published September 11, 2024 · Recall initiated: August 1, 2024

Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

A defect may cause an uncontrolled medication flow condition which may result in a dose greater than prescribed for the patient (i.e., medication overdose).

What to do

Voluntary: Firm initiated · Telephone

Recall details

Manufacturer
Fresenius Kabi USA, LLC
Distributor
US Distribution to states of: CO, ID, NJ, UT.
Lot
Product Code: SET-0013-25; UDI-DI: 00811505030054; Lot number: 3010538.
Risk classification
Class I
Area (FDA)
device
Country
United States

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