Z-0620-2024Class I

regard Operative LAP, Item Number 800943001; surgical convenience kit

Name: Z-0620-2024 regard Operative LAP, Item Number 800943001; surgical convenience kit
Creator: ROi CPS LLC
Published: 2023-12-18
License: https://open.fda.gov/license/

ROi CPS LLC / initiated 2023-12-18 / Terminated / root cause: manufacturing process

FDA source

ROi CPS LLC began a recall of regard Operative LAP, Item Number 800943001; surgical convenience kit on 2023-12-18. FDA classified it as Class I and gives the reason as "Surgical convenience kits were manufactured with a component which was subsequently recalled by Nurse Assist". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0620-2024
Classification: Class I
Status: Terminated
Initiated: 2023-12-18
Posted: 2024-01-12
Terminated: 2024-10-03
Recalling firm: ROi CPS LLC
Product: regard Operative LAP, Item Number 800943001; surgical convenience kit
Product code: LRO General Surgery Tray
Reason for recall: Surgical convenience kits were manufactured with a component which was subsequently recalled by Nurse Assist.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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.
Quantity in commerce: 345 units
Distribution: US distribution to Louisiana
Product codes and lots: UDI/DI 10194717111863, Lot Numbers: 94792, 95613, 96003, 96845

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0620-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0620-2024	Class I	Terminated	Voluntary: Firm initiated	2024-01-24	2024-01-12

Product code LRO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)