FDAClass IIDecember 16, 2020

Mani Trocar KIT recall

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

Why was Mani Trocar KIT recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot Codes: V180077300, Exp Date: 2020/10 and V200009500, EXp Date: 2022/03

Product
MANI TROCAR KIT 23G S - Product Usage: for use in injecting perfusate or aspirating out intraocular materials during ophthalmic surgery, Ref: MTK 23S
Recalling firm
Mani, Inc. - Kiyohara Facility
Quantity
6 units (US)
Distribution
US Nationwide distribution in the state of MO.
Recall date
December 16, 2020
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls