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
- FDA-Drug2026-06-17Fresenius Kabi epinephrine injection recalled for failed impurity specifications
- FDA-Drug2026-04-15Fresenius Kabi sodium chloride injection recalled for sterility assurance
- FDA-Drug2026-04-15Fresenius Kabi sodium chloride injection recalled for sterility assurance
- FDA-Drug2026-04-15Fresenius Kabi sodium chloride injection recalled for sterility concerns
- FDA-Drug2026-04-15Fresenius Kabi sodium chloride injection recalled for lack of sterility assurance
Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief