Recall Z-0250-2022 ยท OJK Eye Tray
ROi CPS LLC
REGARD Basic Cataract tray
| Date | Aug 10, 2021 |
| Status | Terminated |
| Reason | Povidone-Iodine swabstick manufactured by PDI, Inc. recalled due to Out of Specifications was used as a component in some of the ROI CPS, LLC products. |
| Root cause | Nonconforming Material/Component |
| Action | The correction was sent via e-mail on 08-10-2021 instructing the consignees to removed the Swabsticks (3's) and be discarded at time of use. |
| Quantity | 126 trays |
| Distribution | US Nationwide in the states of FL, LA and MO. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.