Device evidence

device-recall:cfres:211717

nuwellis AquaFlexFlow UF 500 Plus, REF 114156, Catalog Number A06163, extracorporeal blood circuit which is used with the Aquadex SmartFlow or Aquadex FlexFlow System

Official recall number

Z-0831-2025

Evidence summary

Product code: KDI
Recall status: Completed
Event initiated: December 11, 2024
Root cause: Under Investigation by firm
Source snapshot: 5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product: Z-0831-2025