Mani, Inc. (Takanezawa Facility) Recall 91829
Description: 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.
Mani, Inc. (Takanezawa Facility) Recall 91829 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1468-2023 |
| Event ID | 91829 |
| Event Description | 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. |
| Product Type | Devices |
| Distribution | Distribution in US - 1 consignee in Missouri |
| Quantity | 45 kits |
| Recall Reason | A packaging defect may compromise the sterile barrier. |
| Device Classification | 20230503 |
| Device Code Info | UDI-DI: 14546951403956 (Model MTK25S) Mani Trocar Kit: 1) Model MTK23S, Lot V210028903 (exp. 2024-03) 2) Model MTK25S, Lot V210009900 (exp. 2023-03) 3) Model MTK25S, Lot V210006701 (exp. 2023-04) 4) Model MTK25S, Lot V210009101 (exp. 2023-11) 5) Model MTK25S, Lot V220016001 (exp. 2024-11-08) |
| Center Classification Date | 20230426 |
| Recall Initiation Date | 20230220 |
| Recalling Firm | Mani, Inc. (Takanezawa Facility) |
| Initial Notification | |
| Similar To |