Recall Z-1468-2023 ยท NGY Cannula, Trocar, Ophthalmic
Mani, Inc. - Kiyohara Facility
Mani Trocar Kit, Model MTK23S and Model MTK25S There are 3 kits contained in one box, and sterile 1 kit consists of 3 pcs. trocar with the valved cannula and 1 pc. infusion cannula.
| Date | Apr 26, 2023 (initiated Feb 20, 2023) |
| Status | Terminated |
| Reason | A packaging defect may compromise the sterile barrier. |
| Root cause | Process control |
| Action | Notification to the impacted consignee was made by letter on 03/01/2023. Consignee(s) are to examine inventory and quarantine any affected product. Notification of the recall must be forwarded to any other impacted entities. Consignee(s) are to complete and return the Acknowledgement and Receipt form to the recalling firm. |
| Quantity | 45 kits |
| Distribution | Distribution in US - 1 consignee in Missouri |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.