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 p…

Recall date

February 20, 2023

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1468-2023

FDA classification

Class II

Brand / firm

Mani, Inc. - Kiyohara Facility

Sold / distributed

Distribution in US - 1 consignee in Missouri

Why it was recalled

A packaging defect may compromise the sterile barrier.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.