Mani, Inc. Kiyohara Facility Park 8-3 Kiyoharakogyodanchi; Kiyoharakogyodanchi; Kiyoharakogyodanchi Utsunomiya Japan Recalls
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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.
A packaging defect may compromise the sterile barrier.
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.
MANI TROCAR KIT 23G S - Product Usage: for use in injecting perfusate or aspirating out intraocular materials during ophthalmic surgery, Ref: MTK 23S
Dimensions of the Luer connector parts out of specification, may cause leakage of fluid and unintended disconnection during use
MANI Inc. issued Voluntary Removal letter issued on 10/27/20 via email to the US Distributor stating reason for removal, health risk and action to take: request distributors to return the devices. If there are MANI TROCAR KIT and MANI INFUSION CANNULA in your stock and/or your customer's stock: Please write the returning Q'ty. in the list ,"Returned" If MANI TROCAR KIT and MANI INFUSION CANNULA are already used up : Please write the used Q'ty. in the list , "Used. Please send this sheet and relevant items if you have to our address below. Any costs/fees related to this return shipment should be charged to MANI FedEx account. MANI, INC. 8-3, Kiyohara Industrial Park, Utsunomiya, Tochigi, 321-3231, Japan