ROi CPS LLC regard Operative LAP, Item Number 800943001; surgical convenience kit Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
regard Operative LAP, Item Number 800943001; surgical convenience kit
Brand
ROi CPS LLC
Lot Codes / Batch Numbers
UDI/DI 10194717111863, Lot Numbers: 94792, 95613, 96003, 96845
Products Sold
UDI/DI 10194717111863, Lot Numbers: 94792, 95613, 96003, 96845
ROi CPS LLC is recalling regard Operative LAP, Item Number 800943001; surgical convenience kit due to Surgical convenience kits were manufactured with a component which was subsequently recalled by Nurse Assist.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Surgical convenience kits were manufactured with a component which was subsequently recalled by Nurse Assist.
Recommended Action
Per FDA guidance
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 lacy.stewart@roiscs.com 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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
LA
Page updated: Jan 10, 2026