CareFusion 203, Inc.

FDA Regulatory Profile

Summary

Total Recalls
2 (2 Class I)
510(k) Clearances
0
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2593-2014Class ICareFusion EnVe and ReVel Ventilators. The EnVe/ ReVel Ventilator is designed for use on patientsAugust 8, 2014
Z-2006-2012Class ICareFusion EnVe Ventilator Designed for use on patients who require respiratory support or mechanJune 19, 2012