AccessClosure, Inc., A Cardinal Health Company

FDA Regulatory Profile

AccessClosure, Inc., A Cardinal Health Company appears in FDA public data with 2 recalls, 0 510(k) clearances, 4 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0297-2017, Class II) was initiated on October 6, 2016.

Summary

Total Recalls
2
510(k) Clearances
0
Inspections
4
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0297-2017Class IIThe PAXWIRE Occlusion Balloon System consists of an occlusion catheter, inflation handle and syringeOctober 6, 2016
Z-2329-2016Class II6F/7F MynxGrip Vascular Closure Device; Product Model MX6721, Product Usage: The 6F/7F MynxGripJuly 13, 2016