regard Operative LAP, Item Number 800943001; surgical convenience kit

Surgical convenience kits were manufactured with a component which was subsequently recalled by Nurse Assist.

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.