Device evidence

device-recall:cfres:203981

QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-4X3, Order Number G22654; used to dilate strictures of the biliary tree

Official recall number

Z-0459-2024

Evidence summary

Product code: FGE
Recall status: Open, Classified
Event initiated: November 03, 2023
Root cause: Under Investigation by firm
Source snapshot: 5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product: Z-0459-2024