Device evidence

device-recall:cfres:201725

Flexiva Pulse 242 TracTip Single-Use Laser Fibers -intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy. 5-pack UPN: M006L8405961

Official recall number

Z-2230-2023

Evidence summary

Product code: GEX
Recall status: Open, Classified
Event initiated: May 25, 2023
Root cause: Nonconforming Material/Component
Source snapshot: 5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product: Z-2230-2023