Resource Optimization & Innovation Llc

FDA Regulatory Profile

Summary

Total Recalls
228
510(k) Clearances
0
Inspections
5
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0950-2022Class IIRegard IV Start Kit for preparing and/or dressing a peripheral vein intravenous access siteFebruary 28, 2022
Z-2699-2020Class IIregard Migrating Indicator, STEAM Migrating Indicator Strips, REORDER # 335576REG - Product Usage: TJune 17, 2020
Z-2368-2020Class IIRegard SRHS GIC Port A Cath, Sterile, Qty 20/case - Product Usage: The Saline Flush Syringes are intMay 4, 2020
Z-2369-2020Class IIRegard SRHS Central Line Kit, Sterile, 20/case - Product Usage: The Saline Flush Syringes are intendMay 4, 2020
Z-0169-2018Class IIRegard Custom Surgical Pack Packs contain surgical instruments and accessories intended for use dSeptember 25, 2017
Z-1556-2017Class IIRegard, Item Number: 800091003, Sterile, LD0692C - C Section - FMOL Lady of AngelsJanuary 9, 2017
Z-1633-2017Class IIRegard, Item Number: 800569002, Sterile, CV0659B - Open Heart A&B - Medical Center Santa RosaJanuary 9, 2017
Z-1652-2017Class IIRegard, Item Number: 800414002, Sterile, OR0483B- Total Joint Pk - SpohnJanuary 9, 2017
Z-1590-2017Class IIRegard, Item Number: 800524004, Sterile, LD0608D - C Section - Westover HillsJanuary 9, 2017
Z-1566-2017Class IIRegard, Item Number: 880327009, Sterile, CV0758I - Open Heart A&B - OSUJanuary 9, 2017
Z-1626-2017Class IIRegard, Item Number: 800559002, Sterile, ET0648B - Head & Neck - Childrens Santa RosaJanuary 9, 2017
Z-1637-2017Class IIRegard, Item Number: 800623001, Sterile, NU0787A - Neuro - Medical Center Santa RosaJanuary 9, 2017
Z-1545-2017Class IIRegard, Item Number: 800535001, Sterile, LD0620A - C Section - New BraunfelsJanuary 9, 2017
Z-1551-2017Class IIRegard, Item Number: 800415001, Sterile, OR0484A - Shoulder System Pk - SpohnJanuary 9, 2017
Z-1600-2017Class IIRegard, Item Number: 800533002 Sterile, GS0606B - Abdominal PK - Westover HillsJanuary 9, 2017
Z-1641-2017Class IIRegard, Item Number: 800408002, Sterile, LD0477B - C-Section PK - SpohnJanuary 9, 2017
Z-1557-2017Class IIRegard, Item Number: 880321002, Sterile, GS0752B - Breast PK - OSUJanuary 9, 2017
Z-1640-2017Class IIRegard, Item Number: 800407004, Sterile, OR0476D - Ortho PK - SpohnJanuary 9, 2017
Z-1546-2017Class IIRegard, Item Number: 800560003, Sterile, GS0649C - Lap Chole - Childrens Santa RosaJanuary 9, 2017
Z-1553-2017Class IIRegard, Item Number: 800528004, Sterile, GS0612D - Lap Chole Pk - Westover HillsJanuary 9, 2017