The Recall Desk
HighFDA (Devices)·Z-0558-2021·Announced 2020-12-16

MANI Infusion Cannula 23G S Recalled for Luer Connector Defects

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

What this means for you

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 with a defect that may cause fluid leakage or unintended disconnection during surgery. Per the rubric, this is classified as High (3) because it is a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Mani, Inc. is recalling 60 units of the MANI Infusion Cannula 23G S (Ref: MTC 23S) in the United States. The product is used for injecting perfusate or aspirating intraocular materials during ophthalmic surgery. The recall is due to Luer connector parts that are out of specification, which may cause leakage of fluid and unintended disconnection during use.

The affected units are identified by Lot Codes V180082900 (Expiration Date 2020/11) and V190000100 (Expiration Date 2020/12). The distribution pattern is listed as US Nationwide distribution in the state of MO.

Healthcare providers and consumers should stop using the affected units and contact Mani, Inc. for further instructions.

The recalled product

Product
MANI Infusion Cannula 23G S - Product Usage: for use in injecting perfusate or aspirating out intraocular materials during ophthalmic surgery Ref: MTC 23S
Manufacturer
Mani, Inc. - Kiyohara Facility
Category
Medical Device — Surgical Instruments
Hazard
Affected units
60

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: V180082900
  • Exp. Date: 2020/11 and V190000100
  • Exp Date: 2020/12

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 →

Related recalls

Same manufacturer · Mani, Inc. - Kiyohara Facility

See all →

Same hazard · leakage

See all →