Class II

Medical Device Recall: LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site (Qty 25). Product Code: SET-0032-25.

Fresenius Kabi USA, LLC · June 24, 2025

Reason for Recall

Potential for external cassette leaks

Distribution

US Nationwide distribution in the states of CA, CO, DE, FL, GA, ID, IL, MA, MD, MI, MN, MS, NJ, NV, OK, OR, SC, TX, VA, WA, WI.

States Affected

NATIONWIDE

Quantity Affected

348,150 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-2235-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.