Device product
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.
Z-1468-2023
Product summary
- Event
- Event 91829
- Status
- Terminated
- Classification
- Class II
- Quantity
- 45 kits
- Official record key
device-enforcement:Z-1468-2023
Official wording
Reason: A packaging defect may compromise the sterile barrier.
Code information: 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)
Distribution pattern: Distribution in US - 1 consignee in Missouri
Derived failure modes
-
Labeling or packaging
packaging defect
-
Sterility assurance
packaging defect may compromise the sterile