Mani, Inc. - Kiyohara Facility: 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. infu

Hazard

A packaging defect may compromise the sterile barrier.

Details from the source

Reason for recall: A packaging defect may compromise the sterile barrier. Distribution: Distribution in US - 1 consignee in Missouri Quantity: 45 kits Lot/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)

UPC codes

14546951403956

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.