FDA Device

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.

Hazard

A packaging defect may compromise the sterile barrier.

What You Should Do

Remedy

Notification to the impacted consignee was made by letter on 03/01/2023. Consignee(s) are to examine inventory and quarantine any affected product. Notification of the recall must be forwarded to any other impacted entities. Consignee(s) are to complete and return the Acknowledgement and Receipt form to the recalling firm.

Products

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.
Brand
Mani, Inc. Kiyohara Facility Park 8-3 Kiyoharakogyodanchi; Kiyoharakogyodanchi; Kiyoharakogyodanchi Utsunomiya Japan
UPC
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)

Units Affected

45 kits