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-1604-2017Class IIRegard, Item Number: 800546001 Sterile, GS0635A - Abdominal - Medical Center Santa RosaJanuary 9, 2017
Z-1621-2017Class IIRegard, Item Number: 800558001, Sterile, OR0647A - Extremity - Childrens Santa RosaJanuary 9, 2017
Z-1617-2017Class IIRegard, Item Number: 800555001, Sterile, HT0644A - Pediatric Card Cath - Childrens Santa RosaJanuary 9, 2017
Z-1585-2017Class IIRegard, Item Number: 800422002, Sterile, OR0491B - Arthroscopy PK - SpohnJanuary 9, 2017
Z-1582-2017Class IIRegard, Item Number: 800414, Sterile, OR0483 - Total Joint PK - SpohnJanuary 9, 2017
Z-1674-2017Class IIRegard, Item Number: 800533001, Sterile, GS0606A - Abdominal Pk - Westover HillsJanuary 9, 2017
Z-1608-2017Class IIRegard, Item Number: 800550001, Sterile, OR0639A - Hip Shoulder - Medical Center Santa RosaJanuary 9, 2017
Z-1584-2017Class IIRegard, Item Number: 800418001, Sterile, GY0487A - Major Vaginal PK - SpohnJanuary 9, 2017
Z-1645-2017Class IIRegard, Item Number: 800409003, Sterile, GS0478B - Lap Chole PK - SpohnJanuary 9, 2017
Z-1553-2017Class IIRegard, Item Number: 800528004, Sterile, GS0612D - Lap Chole Pk - Westover HillsJanuary 9, 2017
Z-1662-2017Class IIRegard, Item Number: 800419002, Sterile, GY0488B - D&C Pk - SpohnJanuary 9, 2017
Z-1554-2017Class IIRegard, Item Number: 800036005, Sterile, LD0274E - C Section Pack - FMOL St FrancisJanuary 9, 2017
Z-1642-2017Class IIRegard, Item Number: 800408003, Sterile, LD0477C - C-Section PK - SpohnJanuary 9, 2017
Z-1549-2017Class IIRegard, Item Number: 800414003, Sterile, OR0483C - Total Joint Pk - SpohnJanuary 9, 2017
Z-1627-2017Class IIRegard, Item Number: 800559003, Sterile, ET0648C - Head & Neck - Childrens Santa RosaJanuary 9, 2017