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U.S. Department of Health and Human Services

Class 2 Device Recall MANI Infusion Cannula

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  Class 2 Device Recall MANI Infusion Cannula see related information
Date Initiated by Firm October 27, 2020
Create Date December 10, 2020
Recall Status1 Terminated 3 on August 11, 2021
Recall Number Z-0558-2021
Recall Event ID 86873
Product Classification Cannula, trocar, ophthalmic - Product Code NGY
Product MANI Infusion Cannula 23G S - Product Usage: for use in injecting perfusate or aspirating out intraocular materials during ophthalmic surgery Ref: MTC 23S
Code Information Lot Codes: V180082900, Exp. Date: 2020/11 and V190000100, Exp Date: 2020/12
Recalling Firm/
Manufacturer		 Mani, Inc. - Kiyohara Facility
Park 8-3
Kiyoharakogyodanchi; Kiyoharakogyodanchi; Kiyoharakogyodanchi
Utsunomiya Japan
Manufacturer Reason
for Recall		 Dimensions of the Luer connector parts out of specification, may cause leakage of fluid and unintended disconnection during use
FDA Determined
Cause 2		 Unknown/Undetermined by firm
Action 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
Quantity in Commerce 60 units (US)
Distribution US Nationwide distribution in the state of MO.
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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