Recall Z-1468-2023— Mani, Inc. - Kiyohara Facility
Class II · Terminated
Class II FDA medical device recall by Mani, Inc. - Kiyohara Facility, initiated 2023-02-20, terminated 2025-05-19. FDA's recall record names no specific 510(k) clearance for this event. 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: A packaging defect may compromise the sterile barrier..
- Recalling firm
- Mani, Inc. - Kiyohara Facility
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2023-02-20
- Terminated
- 2025-05-19
- Firm location
- Utsunomiya, N/A, Japan
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.