FDA-Device2025-08-06Class II

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

Fresenius Kabi USA, LLC
Hazard

Potential for external cassette leaks

Sold states
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.
Affected count
19,225 units
Manufactured in
50 High St Ste 50, North Andover, MA, United States
Products
LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty 25). Product Code: SET-0013-25.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2232-2025

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