Class II
Medical Device Recall: LVP Blood Products Administration Set Dual-Inlet, Low-Sorbing, Y-Site, Mesh Filter (Qty 20). Product Code: SET-0014-20.
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
14,280 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-2233-2025
Status: ongoing
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