FDA recall Z-1468-2023

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.

Reason for recall

A packaging defect may compromise the sterile barrier.

Distribution

Distribution in US - 1 consignee in Missouri

Key facts

Status

Terminated

Initiation date

2023-02-20

Report date

2023-05-03

Termination date

2025-05-19

Voluntary/Mandated

Voluntary: Firm initiated

Location

Utsunomiya, N/A, Japan

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1468-2023