Home / Recalls / Medical Devices
Mani, Inc. - Kiyohara Facility recalls Mani Trocar Kit, Model MTK23S and Model MTK25S There are 3 kits contained in one box, and sterile 1 kit consists of 3
Recalled May 3, 2023 · FDA recall Z-1468-2023 · Mani, Inc. - Kiyohara Facility
Hazard
A packaging defect may compromise the sterile barrier. · FDA Class II
Units
45 kits
Sold at
Distribution in US - 1 consignee in Missouri
Description
A packaging defect may compromise the sterile barrier.
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.
Manufacturer(s)
Mani, Inc. - Kiyohara Facility
Made in
Japan
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →