Carefusion Corporation

FDA Regulatory Profile

Summary

Total Recalls
3 (1 Class I)
510(k) Clearances
0
Inspections
4
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1098-2013Class IAlaris PC unit model 8015 with software version 9.12 Product Usage: The Alaris PC unit is the ceMarch 6, 2013
Z-1112-2013Class IIAlaris PC unit model 8015 with software version 9.12 Product Usage: The Alaris PC unit is the March 6, 2013
Z-1015-2013Class IIPyxis Anesthesia System Model 2000 (PAS 2000) Product Usage: The PAS 2000 is an anesthesia medNovember 20, 2009