CFAI
C.F.A.I.
Government Data Intelligence Services

Resource Optimization & Innovation Llc

Company MO
Found in 2 federal databases · 173 total records
fda 172 records
FDA Device Recall: regard Migrating Indicator, STEAM Migrating Indicator Strips, REORDER # 335576RE 2020-08-05
Class II — The firm received reports from customer that the Regard Migrating Indicator shown malfunctions and does not go into the "accept" window at the time of use.
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FDA Device Recall: Regard SRHS Central Line Kit, Sterile, 20/case - Product Usage: The Saline Flush 2020-06-24
Class II — There is a potential for the product to exhibit holes in the packaging, which impacts package integrity and potentially compromises a sterile field.
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FDA Recall: Resource Optimization & Innovation Llc — Class II 20170405
Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a lig | Product: Regard, Item Number: 800526003 Sterile...
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FDA Recall: Resource Optimization & Innovation Llc — Class II 20170405
Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a lig | Product: Regard, Item Number: 800415003, Steril...
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FDA Recall: Resource Optimization & Innovation Llc — Class II 20170405
Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a lig | Product: Regard, Item Number: 800551002, Steril...
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FDA Recall: Resource Optimization & Innovation Llc — Class II 20170405
Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a lig | Product: Regard, Item Number: 800410004, Steril...
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FDA Recall: Resource Optimization & Innovation Llc — Class II 20170405
Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a lig | Product: Regard, Item Number: 800567003, Steril...
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FDA Recall: Resource Optimization & Innovation Llc — Class II 20170405
Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a lig | Product: Regard, Item Number: 880326001, Steril...
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FDA Recall: Resource Optimization & Innovation Llc — Class II 20170405
Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a lig | Product: Regard, Item Number: 800550001, Steril...
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FDA Recall: Resource Optimization & Innovation Llc — Class II 20170405
Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a lig | Product: Regard, Item Number: 800558003, Steril...
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FDA Recall: Resource Optimization & Innovation Llc — Class II 20170405
Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a lig | Product: Regard, Item Number: 800560002, Steril...
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FDA Recall: Resource Optimization & Innovation Llc — Class II 20170405
Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a lig | Product: Regard, Item Number: 880328002, Steril...
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FDA Recall: Resource Optimization & Innovation Llc — Class II 20170405
Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a lig | Product: Regard, Item Number: 800560003, Steril...
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FDA Recall: Resource Optimization & Innovation Llc — Class II 20170405
Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a lig | Product: Regard, Item Number: 800528005 Sterile...
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FDA Recall: Resource Optimization & Innovation Llc — Class II 20170405
Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a lig | Product: Regard, Item Number: 800413005, Steril...
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FDA Recall: Resource Optimization & Innovation Llc — Class II 20170405
Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a lig | Product: Regard, Item Number: 800430005, Steril...
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FDA Recall: Resource Optimization & Innovation Llc — Class II 20170405
Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a lig | Product: Regard, Item Number: 800415001, Steril...
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FDA Recall: Resource Optimization & Innovation Llc — Class II 20170405
Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a lig | Product: Regard, Item Number: 800535001, Steril...
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FDA Device Recall: Regard Custom Surgical Pack Packs contain surgical instruments and accessorie 2017-11-29
Class II — Resource Optimization & Innovation, LLC (ROi) received a recall notice from BD for an incorrect label on 3ml ChloraPrep With Tint, Product Code (REF) 260415NS, NDC 054365-400-11, Lot 709662...
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FDA Device Recall: Regard, Item Number: 800526003 Sterile, ET0610C - Head and Neck - Westover Hills 2017-04-05
Class II — Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.
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FDA Device Recall: Regard, Item Number: 800415003, Sterile, OR0484C- Shoulder System Pk - Spohn 2017-04-05
Class II — Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.
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FDA Device Recall: Regard, Item Number: 800551002, Sterile, GS0640B - Lap Chole - Medical Center Sa 2017-04-05
Class II — Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.
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FDA Device Recall: Regard, Item Number: 800410004, Sterile, CV0479D- Open Heart PK - Spohn 2017-04-05
Class II — Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.
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FDA Device Recall: Regard, Item Number: 800567003, Sterile, GY0656C - Robotic Hysterectomy - Alamo 2017-04-05
Class II — Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.
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FDA Device Recall: Regard, Item Number: 880326001, Sterile, GS0757A - Major Basin - OSU 2017-04-05
Class II — Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.
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FDA Device Recall: Regard, Item Number: 800550001, Sterile, OR0639A - Hip Shoulder - Medical Center 2017-04-05
Class II — Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.
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FDA Device Recall: Regard, Item Number: 800558003, Sterile, OR0647C - Extremity - Childrens Santa R 2017-04-05
Class II — Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.
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FDA Device Recall: Regard, Item Number: 800560002, Sterile, GS0649B - Lap Chole - Childrens Santa R 2017-04-05
Class II — Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.
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FDA Device Recall: Regard, Item Number: 880328002, Sterile, HT0759B - Pacemaker Pk - OSU 2017-04-05
Class II — Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.
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FDA Device Recall: Regard, Item Number: 800560003, Sterile, GS0649C - Lap Chole - Childrens Santa 2017-04-05
Class II — Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.
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FDA Device Recall: Regard, Item Number: 800528005 Sterile, GS0612E - Lap Chole PK - Westover Hills 2017-04-05
Class II — Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.
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FDA Device Recall: Regard, Item Number: 800413005, Sterile, CV0482E- Vascular PK - Spohn 2017-04-05
Class II — Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.
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FDA Device Recall: Regard, Item Number: 800430005, Sterile, LD0499E - C Section Pk - Cabrini 2017-04-05
Class II — Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.
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FDA Device Recall: Regard, Item Number: 800415001, Sterile, OR0484A - Shoulder System Pk - Spohn 2017-04-05
Class II — Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.
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FDA Device Recall: Regard, Item Number: 800535001, Sterile, LD0620A - C Section - New Braunfels 2017-04-05
Class II — Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.
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FDA Device Recall: Regard, Item Number: 880328001, Sterile, HT0759A - Pacemaker Pk - OSU 2017-04-05
Class II — Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.
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FDA Device Recall: Regard, Item Number: 800528002 Sterile, GS0612B - Lap Chole PK - Westover Hills 2017-04-05
Class II — Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.
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FDA Device Recall: Regard, Item Number: 800091002, Sterile, LD0692B - C Section - FMOL Lady of Ang 2017-04-05
Class II — Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.
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FDA Device Recall: Regard, Item Number: 800417002, Sterile, GY0486B - Laparoscopy Pk - Spohn 2017-04-05
Class II — Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.
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FDA Device Recall: Regard, Item Number: 800562001, Sterile, NU0651A - Neuro - Childrens Santa Rosa 2017-04-05
Class II — Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.
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FDA Device Recall: Regard, Item Number: 800557001, Sterile, LD0646A - C Section - Childrens Santa R 2017-04-05
Class II — Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.
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FDA Device Recall: Regard, Item Number: 800414003, Sterile, OR0483C - Total Joint Pk - Spohn 2017-04-05
Class II — Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.
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FDA Device Recall: Regard, Item Number: 800508004, Sterile, LD0586D - C Section - Jasper 2017-04-05
Class II — Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.
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FDA Device Recall: Regard, Item Number: 800414002, Sterile, OR0483B- Total Joint Pk - Spohn 2017-04-05
Class II — Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.
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FDA Device Recall: Regard, Item Number: 800562002, Sterile, NU0651B - Neuro - Childrens Santa Rosa 2017-04-05
Class II — Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.
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FDA Device Recall: Regard, Item Number: 800326002, Sterile, GS0757B - Major Basin - OSU 2017-04-05
Class II — Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.
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FDA Device Recall: Regard, Item Number: 800419002, Sterile, GY0488B - D&C Pk - Spohn 2017-04-05
Class II — Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.
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FDA Device Recall: Regard, Item Number: 800524003, Sterile, LD0608C - C Section - Westover Hills 2017-04-05
Class II — Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.
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FDA Device Recall: Regard, Item Number: 800410003, Sterile, CV0479C - Open Heart PK - Spohn 2017-04-05
Class II — Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.
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FDA Device Recall: Regard, Item Number: 800533001, Sterile, GS0606A - Abdominal Pk - Westover Hills 2017-04-05
Class II — Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.
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FDA Device Recall: Regard, Item Number: 880323001, Sterile, LD0754A - C Section - OSU 2017-04-05
Class II — Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.
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FDA Device Recall: Regard, Item Number: 800422003, Sterile, OR0491C - Arthroscopy Pk - Spohn 2017-04-05
Class II — Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.
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FDA Device Recall: Regard, Item Number: 800036005, Sterile, LD0274E - C Section Pack - FMOL St Fra 2017-04-05
Class II — Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.
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FDA Device Recall: Regard, Item Number: 800558004, Sterile, OR0647D - Extremity - Childrens Santa R 2017-04-05
Class II — Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.
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FDA Device Recall: Regard, Item Number: 800415002, Sterile, OR0484B- Shoulder System Pk - Spohn 2017-04-05
Class II — Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.
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FDA Device Recall: Regard, Item Number: 800599001, Sterile, GS0694A - Robotic Lap - Christus Highla 2017-04-05
Class II — Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.
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FDA Device Recall: Regard, Item Number: 800553001, Sterile, OR0642A - Total Knee - Medical Center S 2017-04-05
Class II — Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.
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FDA Device Recall: Regard, Item Number: 800553003, Sterile, OR0642C - Total Knee - Medical Center S 2017-04-05
Class II — Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.
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FDA Device Recall: Regard, Item Number: 800411003, Sterile, NU0480C- Neuro PK - Spohn 2017-04-05
Class II — Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.
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FDA Device Recall: Regard, Item Number: 800623001, Sterile, NU0787A - Neuro - Medical Center Santa 2017-04-05
Class II — Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.
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FDA Device Recall: Regard, Item Number: 800599001, Sterile, GS0694A - Robotic Lap - Christus Highla 2017-04-05
Class II — Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.
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FDA Device Recall: Regard, Item Number: 880330004, Sterile, OR0761D - Total Hip - OSU 2017-04-05
Class II — Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.
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FDA Device Recall: Regard, Item Number: 800599003, Sterile, GS0694C - Robotic Lap - Christus Highla 2017-04-05
Class II — Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.
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FDA Device Recall: Regard, Item Number: 880331002, Sterile, OR0762B - Total Knee - OSU 2017-04-05
Class II — Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.
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FDA Device Recall: Regard, Item Number: 800528004, Sterile, GS0612D - Lap Chole Pk - Westover Hill 2017-04-05
Class II — Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.
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FDA Device Recall: Regard, Item Number: 800401002, Sterile, GS0470B - Lap PK - Spohn 2017-04-05
Class II — Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.
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FDA Device Recall: Regard, Item Number: 800559003, Sterile, ET0648C - Head & Neck - Childrens Santa 2017-04-05
Class II — Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.
View Source
FDA Device Recall: Regard, Item Number: 800430004, Sterile, LD0499D - C Section Pk - Cabrini 2017-04-05
Class II — Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.
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FDA Device Recall: Regard, Item Number: 880327009, Sterile, CV0758I - Open Heart A&B - OSU 2017-04-05
Class II — Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.
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FDA Device Recall: Regard, Item Number: 800557002, Sterile, LD0646B - C Section - Childrens Santa R 2017-04-05
Class II — Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.
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FDA Device Recall: Regard, Item Number: 800418002, Sterile, GY0487B - Major Vaginal Pk - Spohn 2017-04-05
Class II — Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.
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FDA Device Recall: Regard, Item Number: 800091003, Sterile, LD0692C - C Section - FMOL Lady of Ang 2017-04-05
Class II — Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.
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FDA Device Recall: Regard, Item Number: 800407003, Sterile, OR0476C - Ortho Pk - Spohn 2017-04-05
Class II — Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.
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FDA Device Recall: Regard, Item Number: 880327008, Sterile, CV0758H - Open Heart A&B - OSU 2017-04-05
Class II — Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.
View Source
FDA Device Recall: Regard, Item Number: 880341001, Sterile, GS0775A - Laparoscopic - OSU 2017-04-05
Class II — Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.
View Source
FDA Device Recall: Regard, Item Number: 800508004, Sterile, LD0586D - C Section - Jasper 2017-04-05
Class II — Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.
View Source
FDA Device Recall: Regard, Item Number: 800413004, Sterile, CV0482D- Vascular PK - Spohn 2017-04-05
Class II — Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.
View Source
FDA Device Recall: Regard, Item Number: 800413003, Sterile, CV0482C - Vascular PK - Spohn 2017-04-05
Class II — Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.
View Source
FDA Device Recall: Regard, Item Number: 800527003 Sterile, OR0611C - Hip Shoulder PK - Westover Hil 2017-04-05
Class II — Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.
View Source
FDA Device Recall: Regard, Item Number: 800525001, Sterile, OR0609A - Extremity Pack - Westover Hil 2017-04-05
Class II — Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.
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FDA Device Recall: Regard, Item Number: 800555002, Sterile, HT0644B - Pediatric Card Cath - Childre 2017-04-05
Class II — Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.
View Source
FDA Device Recall: Regard, Item Number: 800526002 Sterile, ET0610B - Head and Neck - Westover Hills 2017-04-05
Class II — Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.
View Source
FDA Device Recall: Regard, Item Number: 800559002, Sterile, ET0648B - Head & Neck - Childrens Santa 2017-04-05
Class II — Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.
View Source
FDA Device Recall: Regard, Item Number: 800551003, Sterile, GS0640C - Lap Chole - Medical Center Sa 2017-04-05
Class II — Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.
View Source
FDA Device Recall: Regard, Item Number: 800546002, Sterile, GS0635B - Abdominal - Medical Center Sa 2017-04-05
Class II — Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.
View Source
FDA Device Recall: Regard, Item Number: 800508003, Sterile, LD0586C - C Section - Jasper 2017-04-05
Class II — Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.
View Source
FDA Device Recall: Regard, Item Number: 800407004, Sterile, OR0476D - Ortho PK - Spohn 2017-04-05
Class II — Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.
View Source
FDA Device Recall: Regard, Item Number: 800417001, Sterile, GY0486A - Laparoscopy Pk - Spohn 2017-04-05
Class II — Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.
View Source
FDA Device Recall: Regard, Item Number: 800401001, Sterile, GS0470A - Lap PK - Spohn 2017-04-05
Class II — Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.
View Source
FDA Device Recall: Regard, Item Number: 800422002, Sterile, OR0491B - Arthroscopy PK - Spohn 2017-04-05
Class II — Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.
View Source
FDA Device Recall: Regard, Item Number: 800425, Sterile, CV0494 - Av Access PK - Spohn 2017-04-05
Class II — Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.
View Source
FDA Device Recall: Regard, Item Number: 800416001, Sterile, GY0485A - Robotic Hysterectomy Pk - Spo 2017-04-05
Class II — Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.
View Source
FDA Device Recall: Regard, Item Number: 800408004, Sterile, LD0477D - C-Section PK - Spohn 2017-04-05
Class II — Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.
View Source
FDA Device Recall: Regard, Item Number: 800535002 Sterile, LD0620B - C Section - New Braunfels 2017-04-05
Class II — Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.
View Source
FDA Device Recall: Regard, Item Number: 800422004, Sterile, OR0491D - Arthroscopy Pk - Spohn 2017-04-05
Class II — Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.
View Source
FDA Device Recall: Regard, Item Number: 800548002, Sterile, OR0637B - Extremity - Medical Center Sa 2017-04-05
Class II — Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.
View Source
FDA Device Recall: Regard, Item Number: 800553002, Sterile, OR0642B - Total Knee - Medical Center S 2017-04-05
Class II — Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.
View Source
FDA Device Recall: Regard, Item Number: 880327006, Sterile, CV0758F - Open Heart A&B - OSU 2017-04-05
Class II — Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.
View Source
FDA Device Recall: Regard, Item Number: 800411002, Sterile, NU0480B- Neuro PK - Spohn 2017-04-05
Class II — Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.
View Source
FDA Device Recall: Regard, Item Number: 800409003, Sterile, GS0478B - Lap Chole PK - Spohn 2017-04-05
Class II — Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.
View Source
FDA Device Recall: Regard, Item Number: 800550002, Sterile, OR0639B - Hip Shoulder - Medical Center 2017-04-05
Class II — Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.
View Source
FDA Device Recall: Regard, Item Number: 800558002, Sterile, OR0647B - Extremity - Childrens Santa R 2017-04-05
Class II — Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.
View Source
FDA Device Recall: Regard, Item Number: 880330005, Sterile, OR0761E - Total Hip - OSU 2017-04-05
Class II — Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.
View Source
FDA Device Recall: Regard, Item Number: 800508001, Sterile, LD0586A - C Section - Jasper 2017-04-05
Class II — Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.
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FDA Device Recall: Regard, Item Number: 800410005, Sterile, CV0479E- Open Heart PK - Spohn 2017-04-05
Class II — Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.
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FDA Recall: Resource Optimization & Innovation Llc — Class II 20151014
The kits contain an equipment glove component which may contain splits or holes compromising the sterility. | Product: regard Item Number: 800524001, Sterile, LD0608A - C Section - surgical kit contai...
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FDA Recall: Resource Optimization & Innovation Llc — Class II 20151014
The kits contain an equipment glove component which may contain splits or holes compromising the sterility. | Product: regard Item Number: 800407001, Sterile, OR0476A - Ortho Pk - surgical kit contai...
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FDA Recall: Resource Optimization & Innovation Llc — Class II 20151014
The kits contain an equipment glove component which may contain splits or holes compromising the sterility. | Product: regard Item Number: 800408001, Sterile, LD0477A - C-Section Pk - surgical kit co...
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FDA Recall: Resource Optimization & Innovation Llc — Class II 20151014
The kits contain an equipment glove component which may contain splits or holes compromising the sterility. | Product: regard Item Number: 800422, Sterile, OR0491 - Arthroscopy Pk - surgical kit cont...
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FDA Recall: Resource Optimization & Innovation Llc — Class II 20151014
The kits contain an equipment glove component which may contain splits or holes compromising the sterility. | Product: regard Item Number: 880327002, sterile, CV0758B - Open Heart A&B - surgical kit ...
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FDA Recall: Resource Optimization & Innovation Llc — Class II 20151014
The kits contain an equipment glove component which may contain splits or holes compromising the sterility. | Product: regard Item Number: 800416, Sterile, GY0485 - Robotic Hysterectomy Pkg - surgica...
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FDA Recall: Resource Optimization & Innovation Llc — Class II 20151014
The kits contain an equipment glove component which may contain splits or holes compromising the sterility. | Product: regard Item Number: 880323, Sterile, LD0754 - C Section - surgical kit containin...
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FDA Recall: Resource Optimization & Innovation Llc — Class II 20151014
The kits contain an equipment glove component which may contain splits or holes compromising the sterility. | Product: regard Item Number: 800410001, Sterile, CV0479A - Open Heart Pk - surgical kit c...
View Source
FDA Recall: Resource Optimization & Innovation Llc — Class II 20151014
The kits contain an equipment glove component which may contain splits or holes compromising the sterility. | Product: regard Item Number: 800554, Sterile, GS0643 - Pediatric Basic - surgical kit cont...
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FDA Device Recall: Regard, Item Number 830054001, CV00625A - OPEN HEART A&B - Custom surgical kit f 2015-11-04
Class II — Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled due to compromised package integrity potentially affecting sterility assurance.
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FDA Device Recall: Regard, Item Number 830019, CV0214H -Custom surgical kit for cardiovascular surg 2015-11-04
Class II — Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled due to compromised package integrity potentially affecting sterility assurance.
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FDA Device Recall: Regard, Item Number 800301001, Sterile, CV0708A - OPEN HEART- Custom surgical ki 2015-11-04
Class II — Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled due to compromised package integrity potentially affecting sterility assurance.
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FDA Device Recall: Regard, Item Number 830045, CV0443D - CV BUNDLE - Custom surgical kit for cardio 2015-11-04
Class II — Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled due to compromised package integrity potentially affecting sterility assurance.
View Source
FDA Device Recall: Regard, Item Number 830565001, CV0654A - PEDIATRIC HEART - Custom surgical kit f 2015-11-04
Class II — Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled due to compromised package integrity potentially affecting sterility assurance.
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FDA Device Recall: regard Item Number: 800524001, Sterile, LD0608A - C Section - surgical kit conta 2015-10-14
Class II — The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
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FDA Device Recall: regard Item Number: 800407001, Sterile, OR0476A - Ortho Pk - surgical kit conta 2015-10-14
Class II — The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
View Source
FDA Device Recall: regard Item Number: 800408001, Sterile, LD0477A - C-Section Pk - surgical kit c 2015-10-14
Class II — The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
View Source
FDA Device Recall: regard Item Number: 800422, Sterile, OR0491 - Arthroscopy Pk - surgical kit con 2015-10-14
Class II — The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
View Source
FDA Device Recall: regard Item Number: 880327002, sterile, CV0758B - Open Heart A&B - surgical kit 2015-10-14
Class II — The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
View Source
FDA Device Recall: regard Item Number: 800416, Sterile, GY0485 - Robotic Hysterectomy Pkg - surgic 2015-10-14
Class II — The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
View Source
FDA Device Recall: regard Item Number: 880323, Sterile, LD0754 - C Section - surgical kit containi 2015-10-14
Class II — The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
View Source
FDA Device Recall: regard Item Number: 800410001, Sterile, CV0479A - Open Heart Pk - surgical kit 2015-10-14
Class II — The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
View Source
FDA Device Recall: regard Item Number: 800554, Sterile, GS0643 - Pediatric Basic - surgical kit con 2015-10-14
Class II — The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
View Source
FDA Device Recall: regard Item Number: 800553, Sterile, OR0642 - Total Knee - surgical kit containi 2015-10-14
Class II — The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
View Source
FDA Device Recall: regard Item Number: 800535, Sterile, LD0620 - C Section - surgical kit containin 2015-10-14
Class II — The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
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FDA Device Recall: regard Item Number: 800615, Sterile, CV0741 - Peripheral Vascular - surgical kit 2015-10-14
Class II — The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
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FDA Device Recall: regard Item Number: 800409, Sterile, GS0478 - LAP Chole Pk - surgical kit conta 2015-10-14
Class II — The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
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FDA Device Recall: regard Item Number: 800036002, Sterile, LD0274B - C Section Pack - surgical kit 2015-10-14
Class II — The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
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FDA Device Recall: regard Item Number: 800411, Sterile, NU0480 - Neuro Pk - surgical kit containing 2015-10-14
Class II — The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
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FDA Device Recall: regard Item Number: 800411002, Sterile, NU0480B - Neuro Pk - surgical kit conta 2015-10-14
Class II — The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
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FDA Device Recall: regard Item Number: 800533, Sterile, GS0606 - Abdominal Pk - surgical kit contai 2015-10-14
Class II — The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
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FDA Device Recall: regard Item Number: 880330, Sterile, OR0761 - Total Hip - surgical kit containi 2015-10-14
Class II — The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
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FDA Device Recall: regard Item Number: 800560, Sterile, GS0649 - Lap Chole - surgical kit containin 2015-10-14
Class II — The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
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FDA Device Recall: regard Item Number: 800532, Sterile, GY0616 - Vaginal Hysterectomy - surgical ki 2015-10-14
Class II — The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
View Source
FDA Device Recall: regard Item Number: 800411001, Sterile, NU0480A - Neuro Pk - surgical kit conta 2015-10-14
Class II — The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
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FDA Device Recall: regard Item Number: 800597, Sterile, GY0688 - LAVH - surgical kit containing cov 2015-10-14
Class II — The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
View Source
FDA Device Recall: regard Item Number: 880327, Sterile, CV0758 - Open Heart A&B - surgical kit co 2015-10-14
Class II — The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
View Source
FDA Device Recall: regard Item Number: 800565, Sterile, CV0654 - Pediatric Heart - surgical kit con 2015-10-14
Class II — The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
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FDA Device Recall: regard Item Number: 800566, Sterile, NU0655 - VP Shunt - surgical kit containing 2015-10-14
Class II — The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
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FDA Device Recall: regard Item Number: 800549, Sterile, ET0638 - Head & Neck - surgical kit contain 2015-10-14
Class II — The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
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FDA Device Recall: regard Item Number: 800550, Sterile, OR0639 - Hip Shoulder - surgical kit contai 2015-10-14
Class II — The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
View Source
FDA Device Recall: regard Item Number: 800531, Sterile, NU0615 - Neuro Pk - surgical kit containing 2015-10-14
Class II — The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
View Source
FDA Device Recall: regard Item Number: 800623, Sterile, NU0787 - Neuro - surgical kit containing li 2015-10-14
Class II — The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
View Source
FDA Device Recall: regard Item Number: 800514, Sterile, LD0592 - C Section Pack - surgical kit cont 2015-10-14
Class II — The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
View Source
FDA Device Recall: regard Item Number: 800551, Sterile, GS0640 - Lap Chole - surgical kit containin 2015-10-14
Class II — The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
View Source
FDA Device Recall: regard Item Number: 800091001, Sterile, LD0692A - C Section - surgical kit conta 2015-10-14
Class II — The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
View Source
FDA Device Recall: regard Item Number 800568001, Sterile, OR0658A - Titanium Rib - surgical kit con 2015-10-14
Class II — The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
View Source
FDA Device Recall: regard Item Number: 800569001, Sterile, CV0659A - Open Heart A&B - surgical kit 2015-10-14
Class II — The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
View Source
FDA Device Recall: regard Item Number: 800410, Sterile, CV0479 - Open Heart Pk - surgical kit cont 2015-10-14
Class II — The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
View Source
FDA Device Recall: regard Item Number: 800554002, Sterile, GS0643B - Pediatric Basic - surgical kit 2015-10-14
Class II — The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
View Source
FDA Device Recall: regard Item Number: 800413001, Sterile, CV0482A - Vascular Pk - surgical kit co 2015-10-14
Class II — The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
View Source
FDA Device Recall: regard Item Number 800565001, Sterile, CV0654A - Pediatric Heart - surgical kit 2015-10-14
Class II — The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
View Source
FDA Device Recall: regard Item Number: 800554001, Sterile, GS0643A - Pediatric Basic - surgical kit 2015-10-14
Class II — The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
View Source
FDA Device Recall: regard Item Number: 800568, Sterile, OR0658 - Titanium Rib - surgical kit contai 2015-10-14
Class II — The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
View Source
FDA Device Recall: regard Item Number: 880328, Sterile, HT0759 - Pacemaker Pk - surgical kit conta 2015-10-14
Class II — The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
View Source
FDA Device Recall: regard Item Number: 800401, Sterile, GS0470 - Lap Pk - surgical kit containing 2015-10-14
Class II — The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
View Source
FDA Device Recall: regard Item Number: 800617, Sterile, NU0768 - Neuro Pk - surgical kit containing 2015-10-14
Class II — The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
View Source
FDA Device Recall: regard Item Number: 800091, Sterile, LD0692 - C Section - surgical kit containin 2015-10-14
Class II — The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
View Source
FDA Device Recall: regard Item Number: 880326, Sterile, GS0757 - Major Basin - surgical kit contai 2015-10-14
Class II — The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
View Source
FDA Device Recall: regard Item Number: 800558, Sterile, OR0647 - Extremity - surgical kit containin 2015-10-14
Class II — The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
View Source
FDA Device Recall: regard Item Number: 800415, Sterile, OR0484 - Shoulder System Pk - surgical kit 2015-10-14
Class II — The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
View Source
FDA Device Recall: regard Item Number: 800562, Sterile, NU0651 - Neuro - surgical kit containing co 2015-10-14
Class II — The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
View Source
FDA Device Recall: regard Item Number: 880321, Sterile, GS0752 - Breast Pk - surgical kit contain 2015-10-14
Class II — The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
View Source
FDA Device Recall: regard Item Number: 800418, Sterile, GY0487 - Major Vaginal Pk - surgical kit c 2015-10-14
Class II — The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
View Source
FDA Device Recall: regard Item Number: 880331, Sterile, OR0762 - Total Knee - surgical kit contain 2015-10-14
Class II — The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
View Source
FDA Device Recall: regard Item Number: 800527, Sterile, OR0611 - Hip Shoulder Pk - surgical kit con 2015-10-14
Class II — The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
View Source
FDA Device Recall: Regard Custom Surgical Pack, Item Number: 800208002; Sterile, CV0361B - CABG A&B 2015-09-30
Class II — Surgical kits contain a surgical scrub product which may be chemically contaminated and lack sterility assurance.
View Source
ny_corps 1 records
NY Corp: RESOURCE OPTIMIZATION & INNOVATION, L.L.C. 2023-11-28
FOREIGN LIMITED LIABILITY COMPANY | County: New York | Jurisdiction: Missouri
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C.F.A.I. aggregates publicly available federal records for informational purposes only. Nothing on this site constitutes legal, financial, or professional advice. No claims are made regarding the accuracy or completeness of any data presented.