Z-1468-2023 Class II Terminated

Recalled by Mani, Inc. - Kiyohara Facility — Utsunomiya, N/A

Recall Details

Product Type
Devices
Report Date
May 3, 2023
Initiation Date
February 20, 2023
Termination Date
May 19, 2025
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
45 kits

Product 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.

Reason for Recall

A packaging defect may compromise the sterile barrier.

Distribution Pattern

Distribution in US - 1 consignee in Missouri

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)