Device evidence

device-recall:cfres:197682

Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Custom Packs, REF CB841. Used in Cardiopulmonary bypass.

Official recall number

Z-1026-2023

Evidence summary

Product code: DTZ
Recall status: Open, Classified
Event initiated: December 12, 2022
Root cause: Process change control
Source snapshot: 5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product: Z-1026-2023