C.R. Bard, Inc., Urological Division

FDA Regulatory Profile

Summary

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

Recent Recalls

NumberClassProductDate
Z-0010-2013Class II8 Fr. Bardex Pediatric All-Silicone Foley Catheter with a 3cc balloon. The product is packaged indiSeptember 7, 2012
Z-2327-2012Class IIBard Foley procedural trays packaged in breather bags. The product is packaged ten units in each shJune 29, 2012