Device evidence

device-recall:cfres:124941

S5/C5 Heart-lung machine Product Usage: The StOckert S5/ Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures lasting six (6) hours or less.

Official recall number

Z-0856-2014

Evidence summary

Product code: DTQ
Recall status: Terminated
Event initiated: December 04, 2013
Root cause: Device Design
Source snapshot: 5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product: Z-0856-2014