ROi CPS LLC
Medical device manufacturer in Republic, MO.
0510(k) clearances
0PMA approvals
86recalls
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-1047-2025 Class I | regard Item Number: 830106006, LD01114F - Newborn Kit containing the component Neo-Tee…There is a potential for the Inline Controller to be using the spring out of specification causing a loss of… | 12/26/2024Open, Classified |
| Z-3159-2024 Class II | regard Clinical Packaging Solutions, HT00376I - SPECIAL PROCEDURE, Item Number 800223009Medical convenience kits were distributed with Merit syringes (manufactured by Jiangsu Shenli Medical… | 07/24/2024Open, Classified |
| Z-2685-2024 Class II | Regard Kit containing the Microtek decanterDecanters may have pin holes and tears in sterile packaging that cannot be identified visually. | 06/17/2024Open, Classified |
| Z-0620-2024 Class I | regard Operative LAP, Item Number 800943001; surgical convenience kitSurgical convenience kits were manufactured with a component which was subsequently recalled by Nurse Assist. | 12/18/2023Terminated |
| Z-0596-2024 Class I | Regard Dressing change kit, Item Number 800026006ROi CPS manufactured and distributed medical convenience kits with an irrigation solution component which… | 11/20/2023Terminated |
| Z-0315-2024 Class II | Regard CV PK, Item Numbers a) 880289014, b) 880289015; cardiovascular convenience kitSpecific Regard kits contain the Gentige Chest Drain Products being recalled by Gentige. The Instructions… | 09/21/2023Open, Classified |
| Z-0070-2024 Class II | GS0008 2Y - Burn Pack - STL, Item Number 880082025Medical convenience kit contains Zimmer Dermatome Blades which were recalled by Zimmer due to 38 complaints… | 09/11/2023Open, Classified |
| Z-1438-2023 Class II | Sterile surgical convenience kits: 1. regard Item Number: 880473001, OR01105A - Total…The recalling firm was notified by their supplier that the light handle covers may separate from the light… | 03/22/2023Open, Classified |
| Z-1437-2023 Class II | Sterile surgical convenience kits: 1. regard Item Number: 800756005, NU00961E - OH…The recalling firm was notified by their supplier that the light handle covers may separate from the light… | 03/22/2023Open, Classified |
| Z-1436-2023 Class II | Sterile surgical convenience kit: regard Item Number 800706005, LD0091E - OH C-Section…The recalling firm was notified by their supplier that the light handle covers may separate from the light… | 03/22/2023Open, Classified |
| Z-1435-2023 Class II | Sterile surgical convenience kit: regard Item Number: 800753005, GY00958E - WPH GYN…The recalling firm was notified by their supplier that the light handle covers may separate from the light… | 03/22/2023Open, Classified |
| Z-1434-2023 Class II | Sterile surgical convenience kit: regard Item Number: 880393003, HT00997C - Cardiac Cath.The recalling firm was notified by their supplier that the light handle covers may separate from the light… | 03/22/2023Open, Classified |
| Z-1433-2023 Class II | Sterile surgical convenience kit: regard Item Number: 800718003, GY00923C - WPH Major…The recalling firm was notified by their supplier that the light handle covers may separate from the light… | 03/22/2023Open, Classified |
| Z-1432-2023 Class II | Sterile surgical convenience kits: 1. regard Item Number: 880353009, GS00797I -…The recalling firm was notified by their supplier that the light handle covers may separate from the light… | 03/22/2023Open, Classified |
| Z-1431-2023 Class II | Sterile surgical convenience kits: 1. regard Item Number: 880405003, GS01011C - General…The recalling firm was notified by their supplier that the light handle covers may separate from the light… | 03/22/2023Open, Classified |
| Z-0322-2023 Class II | regard SHOULDER ARTHROSCOPY, OR01103A, Item Number 880471001; ortho surgery convenience…Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled. | 10/20/2022Terminated |
| Z-0321-2023 Class II | regard SPINE, OR01100A, Item Number 880468001; ortho surgery convenience kitSurgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled. | 10/20/2022Terminated |
| Z-0320-2023 Class II | regard HIP ARTHROSCOPY, OR01092B, Item Number 880462002; ortho surgery convenience kitSurgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled. | 10/20/2022Terminated |
| Z-0319-2023 Class II | regard LATERAL SHOULDER, OR01044C, Item Number 880435003; ortho surgery convenience kitSurgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled. | 10/20/2022Terminated |
| Z-0318-2023 Class II | regard SHOULDER, GS00828G, Item Number 880367007; ortho surgery convenience kitSurgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled. | 10/20/2022Terminated |
| Z-0317-2023 Class II | regard PEDIATRIC UROLOGY, GS00467J, Item Number 880306010; uro surgery convenience kitSurgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled. | 10/20/2022Terminated |
| Z-0316-2023 Class II | regard CATARACT, EY00450L, Item Number 880295012; eye surgery convenience kitSurgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled. | 10/20/2022Terminated |
| Z-0315-2023 Class II | regard CATARACT, EY00450K, Item Number 880295011; eye surgery convenience kitSurgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled. | 10/20/2022Terminated |
| Z-0314-2023 Class II | regard MINOR DAVINCI PACK, GS00349M, Item Number 880251013; general surgery convenience…Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled. | 10/20/2022Terminated |
| Z-0313-2023 Class II | regard SPINE PACK , NU00193N, Item Number 880179014; neuro surgery convenience kitSurgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled. | 10/20/2022Terminated |
| Z-0312-2023 Class II | regard NEURO TRAY, NU00160R, Item Number 880158018; neuro surgery convenience kitSurgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled. | 10/20/2022Terminated |
| Z-0311-2023 Class II | regard MINOR NEURO, NU00140AD, Item Number 880135030; neuro surgery convenience kitSurgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled. | 10/20/2022Terminated |
| Z-0310-2023 Class II | regard DAVINCI PACK, GS00137W, Item Number 880132023; gastric surgery convenience kitSurgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled. | 10/20/2022Terminated |
| Z-0309-2023 Class II | regard SHOULDER PACK, GS00125V, Item Number 880120022; ortho surgery convenience kitSurgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled. | 10/20/2022Terminated |
| Z-0308-2023 Class II | regard SHOULDER PK, GS00125U, Item Number 880120021; ortho surgery convenience kitSurgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled. | 10/20/2022Terminated |
| Z-0307-2023 Class II | regard FOOT PACK - MERCY SPRINGFIELD , OR00123Z, Item Number 880118026; ortho surgery…Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled. | 10/20/2022Terminated |
| Z-0306-2023 Class II | regard EYE TRAY, EY00099AE, Item Number 880099031; eye surgery convenience kitSurgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled. | 10/20/2022Terminated |
| Z-0305-2023 Class II | regard SHOULDER ARTHROSCOPY, OR00049Q, Item Number 880044017; ortho surgery convenience…Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled. | 10/20/2022Terminated |
| Z-0304-2023 Class II | regard TOTAL HIP ARTHROPLASTY A&B, OR00032W, Item Number 880028023; ortho surgery…Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled. | 10/20/2022Terminated |
| Z-0303-2023 Class II | regard CVPART1BUNDLE- MERCYSTANTHONY , CV01005H, Item Number 830099008; cardiac surgery…Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled. | 10/20/2022Terminated |
| Z-0302-2023 Class II | regard SPINE , NU00974F, Item Number 800769006; neuro surgery convenience kitSurgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled. | 10/20/2022Terminated |
| Z-0301-2023 Class II | regard VITRECTOMY PK, EY00938C, Item Number 800733003; EYE surgery convenience kitSurgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled. | 10/20/2022Terminated |
| Z-0300-2023 Class II | regard RETINAL PACK, EY00935C, Item Number 800730003; EYE surgery convenience kitSurgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled. | 10/20/2022Terminated |
| Z-0299-2023 Class II | regard MAJOR CRANI, NU00921E, Item Number 800716005; neuro surgery convenience kitSurgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled. | 10/20/2022Terminated |
| Z-0298-2023 Class II | regard ACDF, NU00698I, Item Number 800246009; neuro surgery convenience kitSurgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled. | 10/20/2022Terminated |
| Z-0297-2023 Class II | regard ACDF, NU00698H, Item Number 800246008; neuro surgery convenience kitSurgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled. | 10/20/2022Terminated |
| Z-0296-2023 Class II | regard HAND PACK, OR00594K, Item Number 800243011; ortho surgery convenience kitSurgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled. | 10/20/2022Terminated |
| Z-0295-2023 Class II | regard SPINE PACK,NU00395J, Item Number 800241010; ortho surgery convenience kitSurgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled. | 10/20/2022Terminated |
| Z-0294-2023 Class II | regard SHOULDER W BCH CHAIR, OR00356F, Item Number 800203006; ortho surgery convenience…Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled. | 10/20/2022Terminated |
| Z-0293-2023 Class II | regard MAJOR EAR, ET00326J, Item Number 800070010; ear surgery convenience kitSurgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled. | 10/20/2022Terminated |
| Z-0292-2023 Class II | regard CERVICAL PACK, NU00303H, Item Number 800058008; neuro surgery convenience kitSurgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled. | 10/20/2022Terminated |
| Z-0291-2023 Class II | regard NEURO PACK, NU00278L, Item Number 800040012; nuero surgery convenience kitSurgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled. | 10/20/2022Terminated |
| Z-0290-2023 Class II | regard VITRECTOMY PACK, EY00266H, Item Number 800028008; eye surgery convenience kitSurgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled. | 10/20/2022Terminated |
| Z-0289-2023 Class II | regard SPINE PACK, NU00260H, Item Number 800022008; ortho surgery convenience kitSurgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled. | 10/20/2022Terminated |
| Z-0288-2023 Class II | regard BASIC NEURO, NU00259S, Item Number 800021019; neuro surgery convenience kitSurgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled. | 10/20/2022Terminated |
| Z-0287-2023 Class II | regard BASIC NEURO, NU00259R, Item Number 800021018; neuro surgery convenience kitSurgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled. | 10/20/2022Terminated |
| Z-0286-2023 Class II | regard KYPHOPLASTY, OR01101, Item Number 880469; orthopedic surgery convenience kitSurgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled. | 10/20/2022Terminated |
| Z-0285-2023 Class II | regard TOTAL JOINT, OR00446F, Item Number 880291; orthopedic surgery convenience kitSurgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled. | 10/20/2022Terminated |
| Z-0284-2023 Class II | regard FOOT PACK, OR00123Y, Item Number 880118; orthopedic surgery convenience kitSurgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled. | 10/20/2022Terminated |
| Z-0283-2023 Class II | regard LAMINECTOMY, NU01140, Item Number 900940; neuro surgery convenience kitSurgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled. | 10/20/2022Terminated |
| Z-1408-2022 Class II | Nonsterile convenience kit: regard Item #830014016, LD00199P - C Section Mother.Some nonsterile components that were supposed to be sterile were packaged in nonsterile kits. | 06/03/2022Terminated |
| Z-1407-2022 Class II | Nonsterile convenience kits: (1) regard Item #830099008, CV01005H - CV Part 1 Bundle…Some nonsterile components that were supposed to be sterile were packaged in nonsterile kits. | 06/03/2022Terminated |
| Z-1295-2022 Class II | regard Item Number: 800774001, CV00979A - CV Minor Kit, Sterile.A nonsterile component was packaged in a sterile convenience kit. | 05/20/2022Terminated |
| Z-1255-2022 Class II | regard GS0098C - RESUSABLE RT BRONCH, Item Number: 830086003Convenience kit contained Medline Endoscopy Bedside Cleaning products which were recalled. | 05/03/2022Terminated |
| Z-1250-2022 Class II | Regard Item Number: 800214007 Sterile GS00367 - GASTRO BYPASS - SPARTANBURG. CONMED…Potential for the tip of the electrode to detach during use. | 05/03/2022Terminated |
| Z-1051-2022 Class II | Regard brand CABG Pack A and B - SpartanburgKits were packed into shipping boxes incorrectly. | 03/21/2022Terminated |
| Z-1006-2022 Class II | Convenience kits containing regard IV Start Kits: regard Clinical Packaging Solutions…A drug kit component was recalled by its manufacturer due to the potential for inadequacy of the validation… | 03/18/2022Terminated |
| Z-1005-2022 Class II | Convenience kits containing regard IV Start Kits: (1) regard Clinical Packaging…A drug kit component was recalled by its manufacturer due to the potential for inadequacy of the validation… | 03/18/2022Terminated |
| Z-1004-2022 Class II | Convenience kits containing regard IV Start Kits: (1) regard Clinical Packaging…A drug kit component was recalled by its manufacturer due to the potential for inadequacy of the validation… | 03/18/2022Terminated |
| Z-0837-2022 Class III | Regard Custom Procedure Kits containing BD Luer Lok Access DevicesRecalled devices were packaged in convenience kits. | 02/24/2022Terminated |
| Z-0693-2022 Class II | Regard, TOTAL HIP - SPRINGFIELD, Item No. 8800297010, Case Quantity: 2, SterileProducts are mislabeled with the incorrect product identification on individual kit labeling. | 01/13/2022Terminated |
| Z-0469-2022 Class II | Regard, T AND A - Rogers, sterilized convenience kitsKits lacks rubber latex warning label. | 11/30/2021Terminated |
| Z-0411-2022 Class II | regard Clinical Packaging Solutions Item Number 830096005, OB01054E - Newborn Kit…The kit contains a non-sterile needle. | 11/04/2021Terminated |
| Z-0256-2022 Class II | REGARD Vitrectomy TrayPovidone-Iodine swabstick manufactured by PDI, Inc. recalled due to Out of Specifications was used as a… | 08/10/2021Terminated |
| Z-0255-2022 Class II | REGARD Ultrasound TrayPovidone-Iodine swabstick manufactured by PDI, Inc. recalled due to Out of Specifications was used as a… | 08/10/2021Terminated |
| Z-0254-2022 Class II | REGARD Stereotactic TrayPovidone-Iodine swabstick manufactured by PDI, Inc. recalled due to Out of Specifications was used as a… | 08/10/2021Terminated |
| Z-0253-2022 Class II | REGARD Newborn TrayPovidone-Iodine swabstick manufactured by PDI, Inc. recalled due to Out of Specifications was used as a… | 08/10/2021Terminated |
| Z-0252-2022 Class II | REGARD Ear TrayPovidone-Iodine swabstick manufactured by PDI, Inc. recalled due to Out of Specifications was used as a… | 08/10/2021Terminated |
| Z-0251-2022 Class II | REGARD Core Biopsy TrayPovidone-Iodine swabstick manufactured by PDI, Inc. recalled due to Out of Specifications was used as a… | 08/10/2021Terminated |
| Z-0250-2022 Class II | REGARD Basic Cataract trayPovidone-Iodine swabstick manufactured by PDI, Inc. recalled due to Out of Specifications was used as a… | 08/10/2021Terminated |
| Z-2169-2021 Class II | Regard NEWBORN KIT, LD00201M, Item Number: 830016013. Medical convenience kit which…Instructions for use updated to include the following cautionary statement for the heel warmer, "Activate… | 06/14/2021Terminated |
| Z-2168-2021 Class II | Regard NEWBORN KIT, LD00201K, Item Number: 830016011. Medical convenience kit which…Instructions for use updated to include the following cautionary statement for the heel warmer, "Activate… | 06/14/2021Terminated |
| Z-2167-2021 Class II | Regard NEWBORN KIT, LD00201j, Item Number: 830016010. Medical convenience kit which…Instructions for use updated to include the following cautionary statement for the heel warmer, "Activate… | 06/14/2021Terminated |
| Z-1542-2021 Class II | Regard Dressing Change TrayChloraPrep applicators in the kit can grow organisms that can result in a breach of the applicators package… | 03/26/2021Terminated |
| Z-1376-2021 Class II | Regard, Item Number 830067009, custom cardiovascular procedure kitROi CPS, LLC has become aware, through a vendor issued urgent medical device recall notice, that drapes… | 03/04/2021Open, Classified |
| Z-0737-2021 Class II | Custom procedure packs, containing banded 4x4 Raytec 16ply gauze sponges. 1) Regard…Gauze sponges contained in custom kits may be flaking or fraying. | 11/09/2020Terminated |
| Z-0524-2021 Class II | Regard - Product Usage: Obstetric Gynecologic specialized manual instrument. Labor and…Labeling error, incorrect expiration date. | 10/12/2020Terminated |
| Z-2466-2020 Class II | Respirator Crash Cart KitRoi CPS, LLC has become aware of a labeling error that affects select custom procedure kits. The kits are… | 05/19/2020Terminated |
| Z-2465-2020 Class II | Isolation Droplet Bundle KitRoi CPS, LLC has become aware of a labeling error that affects select custom procedure kits. The kits are… | 05/19/2020Terminated |
| Z-2265-2020 Class II | Regard. Item number: 830034. GS0348D- CVC Triple Lumen 20CM non Sulfa-Mercy.Custom procedure kits contains affected lots of PosiFlush Syringe, a product recalled by BD. | 04/20/2020Terminated |
| Z-0918-2020 Class II | Custom procedure packs, containing Clearlink Continu-Flo, labeled as follows: a) regard…ROi CPS, LLC manufactured custom procedure packs using Clearlink Continu-Flo devices which were subsequently… | 01/03/2020Terminated |