Resource Optimization & Innovation Llc

FDA Regulatory Profile

Resource Optimization & Innovation Llc appears in FDA public data with 228 recalls, 0 510(k) clearances, 5 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0950-2022, Class II) was initiated on February 28, 2022.

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-1628-2017Class IIRegard, Item Number: 800560002, Sterile, GS0649B - Lap Chole - Childrens Santa RosaJanuary 9, 2017
Z-1652-2017Class IIRegard, Item Number: 800414002, Sterile, OR0483B- Total Joint Pk - SpohnJanuary 9, 2017
Z-1657-2017Class IIRegard, Item Number: 800417001, Sterile, GY0486A - Laparoscopy Pk - SpohnJanuary 9, 2017
Z-1582-2017Class IIRegard, Item Number: 800414, Sterile, OR0483 - Total Joint PK - SpohnJanuary 9, 2017
Z-1675-2017Class IIRegard, Item Number: 800568002, Sterile, OR0658 - Titanium Rib - Childrens Santa RosaJanuary 9, 2017
Z-1644-2017Class IIRegard, Item Number: 800409002, Sterile, GS0478B - Lap Chole PK - SpohnJanuary 9, 2017
Z-1655-2017Class IIRegard, Item Number: 800416001, Sterile, GY0485A - Robotic Hysterectomy Pk - SpohnJanuary 9, 2017
Z-1585-2017Class IIRegard, Item Number: 800422002, Sterile, OR0491B - Arthroscopy PK - SpohnJanuary 9, 2017
Z-1613-2017Class IIRegard, Item Number: 800553001, Sterile, OR0642A - Total Knee - Medical Center Santa RosaJanuary 9, 2017
Z-1635-2017Class IIRegard, Item Number: 800599001, Sterile, GS0694A - Robotic Lap - Christus HighlandJanuary 9, 2017
Z-1584-2017Class IIRegard, Item Number: 800418001, Sterile, GY0487A - Major Vaginal PK - SpohnJanuary 9, 2017
Z-1603-2017Class IIRegard, Item Number: 800535002 Sterile, LD0620B - C Section - New BraunfelsJanuary 9, 2017
Z-1604-2017Class IIRegard, Item Number: 800546001 Sterile, GS0635A - Abdominal - Medical Center Santa RosaJanuary 9, 2017
Z-1645-2017Class IIRegard, Item Number: 800409003, Sterile, GS0478B - Lap Chole PK - SpohnJanuary 9, 2017
Z-1674-2017Class IIRegard, Item Number: 800533001, Sterile, GS0606A - Abdominal Pk - Westover HillsJanuary 9, 2017