FDA Recall
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.
Recall: Z-1468-2023
·
Initiated February 20, 2023
Recall
- Recall Number
- Z-1468-2023
- Event Number
- 91829
- Firm
- Mani, Inc. Kiyohara Facility Park 8-3 Kiyoharakogyodanchi; Kiyoharakogyodanchi; Kiyoharakogyodanchi Utsunomiya Japan
- FEI Number
- 3002692886
- Product Code
- NGY
- Status
- Terminated
- Root Cause
- Process control
- Initiated
- February 20, 2023
- Posted
- April 26, 2023
- Terminated
- May 19, 2025
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
A packaging defect may compromise the sterile barrier.
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.
Distribution
Distribution in US - 1 consignee in Missouri
Quantity
45 kits