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U.S. Department of Health and Human Services

Class 2 Device Recall Mani

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  Class 2 Device Recall Mani see related information
Date Initiated by Firm February 20, 2023
Date Posted April 26, 2023
Recall Status1 Open3, Classified
Recall Number Z-1468-2023
Recall Event ID 91829
Product Classification Cannula, trocar, ophthalmic - Product Code NGY
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.
Code Information UDI-DI: 14546951403956 (Model MTK25S) Mani Trocar Kit: 1) Model MTK23S, Lot V210028903 (exp. 2024-03) 2) Model MTK25S, Lot V210009900 (exp. 2023-03) 3) Model MTK25S, Lot V210006701 (exp. 2023-04) 4) Model MTK25S, Lot V210009101 (exp. 2023-11) 5) Model MTK25S, Lot V220016001 (exp. 2024-11-08)
Recalling Firm/
Manufacturer		 Mani, Inc. - Kiyohara Facility
Park 8-3
Kiyoharakogyodanchi; Kiyoharakogyodanchi; Kiyoharakogyodanchi
Utsunomiya Japan
For Additional Information Contact Mr. Kensuke Otawara
286671811
Manufacturer Reason
for Recall		 A packaging defect may compromise the sterile barrier.
FDA Determined
Cause 2		 Process control
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.
Quantity in Commerce 45 kits
Distribution Distribution in US - 1 consignee in Missouri
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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