Bard Medical Division

FDA Regulatory Profile

Summary

Total Recalls
5
510(k) Clearances
0
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0803-2019Class IISureStep(TM) FOLEY TRAY SYSTEM, Preconnected Closed System Foley Tray, Product Codes: A119214M, A11December 13, 2018
Z-0800-2019Class IIBARD SureStep Foley Tray System Bardex I.C. Complete Care Temperature Sensing Infection Control FoleDecember 6, 2018
Z-2536-2018Class IIArctic Sun Temperature Management System, Model 5000. The Arctic Sun¿ 5000 model is a non-invasiJune 13, 2018
Z-2943-2018Class IIBard Midstream Urine Collector with Rigid Funnel and Iodophor Prep Pads. Product Packaging: Three (March 21, 2018
Z-1241-2019Class IIMedivance(R) ARCTIC SUN(R) ARCTICGEL(TM) Pads: Description, Catalog Number a) Intrepid ArcticGel SNovember 8, 2017