Device evidence

device-recall:cfres:197273

Revaclear 400 Dialyzer. Product Code: 114749M. Not distributed in the USA. Used to treat chronic and acute renal failure by hemodialysis.

Official recall number

Z-0761-2023

Evidence summary

Product code: KDI
Recall status: Open, Classified
Event initiated: November 23, 2022
Root cause: Process change control
Source snapshot: 5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product: Z-0761-2023