FDA-Device2025-08-06Class II
LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site (Qty 25). Product Code: SET-0032-25.
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
348,150 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, Dual Y-Site (Qty 25). Product Code: SET-0032-25.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2235-2025More Fresenius Kabi USA, LLC recalls
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- FDA-Drug2026-07-29Fresenius Kabi Xylocaine lidocaine injection recalled for hair contamination
- FDA-Drug2026-07-29Fresenius Kabi glycopyrrolate injection recalled for hair contamination
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