Recall Z-0620-2024 ยท LRO General Surgery Tray
ROi CPS LLC
regard Operative LAP, Item Number 800943001; surgical convenience kit
| Date | Jan 12, 2024 (initiated Dec 18, 2023) |
| Status | Terminated |
| Reason | Surgical convenience kits were manufactured with a component which was subsequently recalled by Nurse Assist. |
| 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 lacy.stewart@roiscs.com 5. Notify any customers to whom you |
| Quantity | 345 units |
| Distribution | US distribution to Louisiana |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.