Fresenius Kabi USA, LLC: IVENIX INFUSION SYSTEM LVP Blood Products Administration Set, Dual-Inlet, Low-Sorbing, Y-Site, Mesh Filter, 15 mL. Intravascular Administration Set.

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.

Details from the source

Reason for recall: 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. Distribution: US distribution: CA, CO, DE, GA, IL, MD, MI, MN, MS, NC, NJ, NV, OK, SC, TX, VA, WA & WI. Quantity: 14,280 units (724 cases) Lot/code info: Model No. SET-0014-20; UDI 20811505030034; Lot No. FA24K05015.

UPC codes

20811505030034

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.