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Terminated

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.

FDA Recall Z-1468-2023 · Posted 2023-04-26

Recalling FirmMani, Inc. - Kiyohara Facility
Recall StatusTerminated
Product CodeNGY
Date Initiated2023-02-20
Date Terminated2025-05-19
Product Quantity45 kits

Reason for Recall

A packaging defect may compromise the sterile barrier.

Firm Action

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.

Root Cause

Process control

Distribution Pattern

Distribution in US - 1 consignee in Missouri

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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