Genesis BPS, LLC.

FDA Regulatory Profile

Summary

Total Recalls
3
510(k) Clearances
1
Inspections
5
Compliance Actions
1

Recent Recalls

NumberClassProductDate
Z-2669-2014Class IIPedi-Pak Pedi-Syringe Filter 35 mL Monoject Syringe Rx Only Genesis BPS, LLC The intended use is tJuly 17, 2014
Z-2668-2014Class IIPedi-Pak Pedi-Syringe Filter 60 mL Becton Dickinson/Monoject Syringe Rx Only Genesis BPS, LLC The July 17, 2014
Z-2667-2014Class IIPedi-Pak Pedi-Syringe Filter 30 mL Becton Dickinson Syringe Rx Only Genesis BPS, LLC The intended July 17, 2014

Recent 510(k) Clearances

K-NumberDeviceDate
K082027FLU-ADMIN, MODELS 60150, 60150C, 60151C, 60153C, 60160February 13, 2009