Carefusion Corporation

FDA Regulatory Profile

Carefusion Corporation appears in FDA public data with 3 recalls — including 1 Class I (most serious) —, 0 510(k) clearances, 4 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1112-2013, Class II) was initiated on March 6, 2013.

Summary

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

Recent Recalls

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