Device evidence

device-recall:cfres:140773

Custom Pak 9319-27. Single-use medical devices and accessories designed by medical professionals for a specific ophthalmic surgical procedure.

Official recall number

Z-0195-2016

Evidence summary

Product code: LRO
Recall status: Terminated
Event initiated: September 21, 2015
Root cause: Mixed-up of materials/components
Source snapshot: 5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product: Z-0195-2016