The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0557-2021·Announced 2020-12-16

Mani Trocar Kit 23G S Recalled for Luer Connector Defects

Mani, Inc. is recalling Trocar Kit 23G S units because Luer connector dimensions are out of specification, which may cause fluid leakage or disconnection during ophthalmic surgery.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device defect that may cause fluid leakage and unintended disconnection during surgery. Per the rubric, this is classified as High because it is a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Mani, Inc. is recalling the MANI TROCAR KIT 23G S (Ref: MTK 23S) due to a manufacturing defect. The product is used for injecting perfusate or aspirating intraocular materials during ophthalmic surgery. The recall involves 6 units distributed in the state of Missouri.

The recall was initiated because the dimensions of the Luer connector parts are out of specification. This defect may cause leakage of fluid and unintended disconnection during use. The affected lot codes are V180077300 (Expiration Date: 2020/10) and V200009500 (Expiration Date: 2022/03).

Healthcare providers and facilities that have received these specific units should stop using them and contact the manufacturer for instructions on return or replacement. The source text does not report any illnesses or injuries associated with this recall.

The recalled product

Product
MANI TROCAR KIT 23G S - Product Usage: for use in injecting perfusate or aspirating out intraocular materials during ophthalmic surgery, Ref: MTK 23S
Manufacturer
Mani, Inc. - Kiyohara Facility
Category
Medical Device — Surgical Instrument
Hazard
Affected units
6

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

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

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 2 recalled by Mani, Inc. - Kiyohara Facility under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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