ROi CPS LLC
15 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for ROi CPS LLC and translate it into plain English — free weekly digest, optional same-day alerts.
- 2025-02-12FDA-DeviceClass Iregard 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..
- 2024-09-25FDA-DeviceClass IIregard 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.
- 2024-08-28FDA-DeviceClass IIRegard Kit containing the Microtek decanter
Decanters may have pin holes and tears in sterile packaging that cannot be identified visually.
- 2024-01-24FDA-DeviceClass Iregard Operative LAP, Item Number 800943001; surgical convenience kit
Surgical convenience kits were manufactured with a component which was subsequently recalled by Nurse Assist.
- 2024-01-10FDA-DeviceClass IRegard 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.
- 2023-11-22FDA-DeviceClass IIRegard 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.
- 2023-10-11FDA-DeviceClass IIGS0008 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.
- 2023-05-03FDA-DeviceClass IISterile 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
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.
- 2023-05-03FDA-DeviceClass IISterile 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.
- 2023-05-03FDA-DeviceClass IISterile 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.
- 2023-05-03FDA-DeviceClass IISterile 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.
- 2023-05-03FDA-DeviceClass IISterile 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.
- 2023-05-03FDA-DeviceClass IISterile 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.
- 2023-05-03FDA-DeviceClass IISterile 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.
- 2023-05-03FDA-DeviceClass IISterile 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.
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