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Terminated

MANI TROCAR KIT 23G S - Product Usage: for use in injecting perfusate or aspirating out intraocular materials during ophthalmic surgery, Ref: MTK 23S

FDA Recall Z-0557-2021 · Posted None

Recalling FirmMani, Inc. - Kiyohara Facility
Recall StatusTerminated
Product CodeNGY
Date Initiated2020-10-27
Date Terminated2021-08-11
Product Quantity6 units (US)

Reason for Recall

Dimensions of the Luer connector parts out of specification, may cause leakage of fluid and unintended disconnection during use

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

Root Cause

Unknown/Undetermined by firm

Distribution Pattern

US Nationwide distribution in the state of MO.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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