FDA-Device2025-06-18Class I
IVENIX INFUSION SYSTEM LVP Blood Products Administration Set, Dual-Inlet, Low-Sorbing, Y-Site, Mesh Filter, 15 mL. Intravascular Administration Set.
Fresenius Kabi USA, LLC
Hazard
Mis-assembly error of Blood Products Administrations Sets where the 200-micron drip chamber filter may be incorrectly positioned and unable to filter out large blood particulates.
Sold states
US distribution: CA, CO, DE, GA, IL, MD, MI, MN, MS, NC, NJ, NV, OK, SC, TX, VA, WA & WI.
Affected count
14,280 units (724 cases)
Manufactured in
50 High St Ste 50, North Andover, MA, United States
Products
IVENIX INFUSION SYSTEM LVP Blood Products Administration Set, Dual-Inlet, Low-Sorbing, Y-Site, Mesh Filter, 15 mL. Intravascular Administration Set.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1869-2025Don't want to check this manually?
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