regard Operative LAP, Item Number 800943001 recallZ-0620-2024 · ROi CPS LLC · initiated Dec 18, 2023
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from ROi CPS LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Surgical convenience kits were manufactured with a component which was subsequently recalled by Nurse Assist.
FDA root cause category: Process control
What the company is doing
ROi CPS issued an "URGENT MEDICAL DEVICE CORRECTION NOTICE" to its sole consignee on 12/18/2023 via email. The notice explained the issue, potential risk to health, and requested the following actions be taken: 1. Check inventory for affected product 2. segregate and quarantine affected product 3. Using the attached template, print warning labels (WARNING - Cardinal Health Item 6146LL 16FR SIL Drain Bag Foley Tray HAS BEEN RECALLED Remove and Discard upon Opening Kit) and affix to product. 4. Respond using reply form and return to [email protected] 5. Notify any customers to whom you distributed the product ROi CPS issued an "URGENT EXPANDED MEDICAL DEVICE CORRECTION NOTICE" to its sole consignee on 01/02/2024 via email. The notice was issued after receiving an expansion of the Urgent kit/Tray Component Recall from their supplier, Cardinal Health. Two additional lots have been added. The actions to be taken are the same as the original notice issued on 12/18/2023. If you have any questions relating to this correction notice, please do not hesitate to contact Manager of Quality and Regulatory Affairs at 417-647-3205.
Recall details
- Recall number
- Z-0620-2024
- Status
- Terminated
- Initiated by the company
- Dec 18, 2023
- Posted by the FDA
- Jan 12, 2024
- Recalling firm
- ROi CPS LLC
- Quantity
- 345 units
- Product code
- LRO
- Distribution
- US distribution to Louisiana
Product description
regard Operative LAP, Item Number 800943001; surgical convenience kit
Code information (models, lots, serial numbers)
UDI/DI 10194717111863, Lot Numbers: 94792, 95613, 96003, 96845
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Regard™ GS01143ARoi Cps, LLC · General Surgery Tray1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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