Recall Z-0290-2023 ยท OJK Eye Tray
ROi CPS LLC
regard VITRECTOMY PACK, EY00266H, Item Number 800028008; eye surgery convenience kit
| Date | Nov 23, 2022 (initiated Oct 20, 2022) |
| Status | Terminated |
| Reason | Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled. |
| Root cause | Component change control |
| Action | ROi CPS, LLC issued a MEDICAL DEVICE CORRECTION NOTICE on 10/20/2022 by email to its consignees. The notice explained the issue, the distribution dates, and kits specific to each consignee, and requested the following: "Actions to be taken by customers: 1. CHECK: Please review your inventory to determine if the manufacturer item numbers and lot numbers listed in the chart above are in your inventory. 2. QUARANTINE: Segregate and quarantine all affected kits in your inventory. 3. LABEL: Use the attached label template (Ro; CPS Correction INC13225-3M Recall Label Template-Avery 5960) to print |
| Quantity | 76 kits |
| Distribution | LA, MO, NC, FL |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.