Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1468-2023 — 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.

U.S. FDA — Device Enforcement · Japan · 2023-02-20 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1468-2023
Date of alert: 2023-02-20
Country / jurisdiction: Japan
Risk level: Class II
Risk type: recall
Brand: Mani, Inc. - Kiyohara Facility
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 14546951403956

Reported risk: A packaging defect may compromise the sterile barrier.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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Recall Z-1468-2023 — 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.

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