Device evidence

device-recall:cfres:139762

regard Item Number: 800514, Sterile, LD0592 - C Section Pack - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROI, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

Official recall number

Z-0045-2016

Evidence summary

Product code: FSY
Recall status: Terminated
Event initiated: April 22, 2015
Root cause: Process control
Source snapshot: 5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product: Z-0045-2016