ROi CPS LLC
Republic, MO, US
ROi CPS LLC appears in FDA device records in Republic, MO. FDA records list no 510(k) clearances, no PMA records and no registered establishments. As of , FDA records show 86 recalls for this company.
FDA records held for this company
- 510(k) clearances
- 0
- PMA records
- 0
- Recall records
- 86
- Registered establishments
- 0
510(k) clearance history
No 510(k) clearance records for this company in the ingested FDA data.
No 510(k) clearance records in the ingested FDA data.
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
No FDA product codes recorded against this company.
Recall records
Showing 25 of 86| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1047-2025 | regard Item Number: 830106006, LD01114F - Newborn Kit containing the component Neo-Tee Resuscitator. Convenience kit to be used in Labor and Delivery. | There is a potential for the Inline Controller to be using the spring out of specification causing a loss of positive pressure resulting in the Neo-Tee Resuscitator and/or Circuit will not reach the high and low ends of the PIP and PEEP pressure ranges impacting effective ventilation of the patient.. | Class I | Open, Classified | |
| Z-3159-2024 | regard Clinical Packaging Solutions, HT00376I - SPECIAL PROCEDURE, Item Number 800223009 | Medical convenience kits were distributed with Merit syringes (manufactured by Jiangsu Shenli Medical Production) which were subsequently recalled. | Class II | Open, Classified | |
| Z-2685-2024 | Regard Kit containing the Microtek decanter | Decanters may have pin holes and tears in sterile packaging that cannot be identified visually. | Class II | Open, Classified | |
| Z-0620-2024 | regard Operative LAP, Item Number 800943001; surgical convenience kit | Surgical convenience kits were manufactured with a component which was subsequently recalled by Nurse Assist. | Class I | Terminated | |
| Z-0596-2024 | Regard Dressing change kit, Item Number 800026006 | ROi CPS manufactured and distributed medical convenience kits with an irrigation solution component which was subsequently recalled by the component manufacturer. | Class I | Terminated | |
| Z-0315-2024 | Regard CV PK, Item Numbers a) 880289014, b) 880289015; cardiovascular convenience kit | Specific Regard kits contain the Gentige Chest Drain Products being recalled by Gentige. The Instructions for Use (IFU) for the chest drains do not provide sufficient precaution instruction for proper set up of catheter(s) and patient tube connections with single collection chamber chest drains. | Class II | Open, Classified | |
| Z-0070-2024 | GS0008 2Y - Burn Pack - STL, Item Number 880082025 | Medical convenience kit contains Zimmer Dermatome Blades which were recalled by Zimmer due to 38 complaints received related to skin grafts being thin and non-uniform when using the affected blades. | Class II | Open, Classified | |
| Z-1438-2023 | Sterile surgical convenience kits: 1. regard Item Number: 880473001, OR01105A - Total Shoulder/Hip; 2. regard Item Number: 880426004, OR01033D - Total Hip; 3. regard Item Number: 880427003, OR01034C - Total Knee; 4. regard Item Number: 880474001, OR01106A - Knee Arthroscopy; 5. regard Item Number: 800772006, OR00977F - OH Total Knee Pack ; 6. regard Item Number: 880403004, OR01009D - Extremity Pack; 7. regard Item Number: 880472001, OR01104A - Basic Pack ; 8. regard Item Number: 880470001, OR01102A - Total Knee ; 9. regard Item Number: 800755006, OR00960F - OH Hip Pack ; 10. regard Item Number: 880471001, OR01103A - Shoulder Arthroscopy ; 11. regard Item Number: 880480001, OR01112A - Hand and Foot ; and 12. regard Item Number: 880468001, OR01100A - Spine. | The recalling firm was notified by their supplier that the light handle covers may separate from the light handle and fall off during use. The light handle covers are a kit component. | Class II | Open, Classified | |
| Z-1437-2023 | Sterile surgical convenience kits: 1. regard Item Number: 800756005, NU00961E - OH Laminectomy Cust Pack; 2. regard Item Number: 880411008, NU01018H - Lumbar Universal ; 3. regard Item Number: 880396007, NU01001G - Craniotomy ; 4. regard Item: 880387005, NU00991E - Ant/Cervical Spine ; and 5. regard Item Number: 800716005, NU00921E - ORMC Major Crani Pack. | The recalling firm was notified by their supplier that the light handle covers may separate from the light handle and fall off during use. The light handle covers are a kit component. | Class II | Open, Classified | |
| Z-1436-2023 | Sterile surgical convenience kit: regard Item Number 800706005, LD0091E - OH C-Section Pack. | The recalling firm was notified by their supplier that the light handle covers may separate from the light handle and fall off during use. The light handle covers are a kit component. | Class II | Open, Classified | |
| Z-1435-2023 | Sterile surgical convenience kit: regard Item Number: 800753005, GY00958E - WPH GYN Laparoscopy Pack. | The recalling firm was notified by their supplier that the light handle covers may separate from the light handle and fall off during use. The light handle covers are a kit component. | Class II | Open, Classified | |
| Z-1434-2023 | 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 handle and fall off during use. The light handle covers are a kit component. | Class II | Open, Classified | |
| Z-1433-2023 | Sterile surgical convenience kit: regard Item Number: 800718003, GY00923C - WPH Major Vaginal Pack. | The recalling firm was notified by their supplier that the light handle covers may separate from the light handle and fall off during use. The light handle covers are a kit component. | Class II | Open, Classified | |
| Z-1432-2023 | Sterile surgical convenience kits: 1. regard Item Number: 880353009, GS00797I - Laparotomy Pk; 2. regard Item Number: 880429002, GS01036B - Universal Custom ; 3. regard Item Number: 800725004, GS00930D - OH Base Robot Pack ; 4. regard Item Number: 800725005, GS00930E - OH Base Robot Pack ; 5. regard Item Number: 800395003, GS01000C - Colon Lithotomy and 6. regard Item Number: 880391002, GS00995B - Basic Laparotomy. | The recalling firm was notified by their supplier that the light handle covers may separate from the light handle and fall off during use. The light handle covers are a kit component. | Class II | Open, Classified | |
| Z-1431-2023 | Sterile surgical convenience kits: 1. regard Item Number: 880405003, GS01011C - General Laparoscopy; 2. regard Item Number: 880424004, GS01031D - Thoracic. | The recalling firm was notified by their supplier that the light handle covers may separate from the light handle and fall off during use. The light handle covers are a kit component. | Class II | Open, Classified | |
| Z-0322-2023 | regard SHOULDER ARTHROSCOPY, OR01103A, Item Number 880471001; ortho surgery convenience kit | Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled. | Class II | Terminated | |
| Z-0321-2023 | regard SPINE, OR01100A, Item Number 880468001; ortho surgery convenience kit | Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled. | Class II | Terminated | |
| Z-0320-2023 | regard HIP ARTHROSCOPY, OR01092B, Item Number 880462002; ortho surgery convenience kit | Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled. | Class II | Terminated | |
| Z-0319-2023 | regard LATERAL SHOULDER, OR01044C, Item Number 880435003; ortho surgery convenience kit | Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled. | Class II | Terminated | |
| Z-0318-2023 | regard SHOULDER, GS00828G, Item Number 880367007; ortho surgery convenience kit | Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled. | Class II | Terminated | |
| Z-0317-2023 | regard PEDIATRIC UROLOGY, GS00467J, Item Number 880306010; uro surgery convenience kit | Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled. | Class II | Terminated | |
| Z-0316-2023 | regard CATARACT, EY00450L, Item Number 880295012; eye surgery convenience kit | Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled. | Class II | Terminated | |
| Z-0315-2023 | regard CATARACT, EY00450K, Item Number 880295011; eye surgery convenience kit | Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled. | Class II | Terminated | |
| Z-0314-2023 | regard MINOR DAVINCI PACK, GS00349M, Item Number 880251013; general surgery convenience kit | Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled. | Class II | Terminated | |
| Z-0313-2023 | regard SPINE PACK , NU00193N, Item Number 880179014; neuro surgery convenience kit | Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled. | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain