Device evidence

device-recall:cfres:204146

Integra Cranial access kit (without Prep solutions) Bit and Guard-For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: INS5HND

Official recall number

Z-0491-2024

Evidence summary

Product code: HBG
Recall status: Open, Classified
Event initiated: October 19, 2023
Root cause: Process control
Source snapshot: 5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product: Z-0491-2024