Medical device recalls Moderate risk

Mani, Inc. - Kiyohara Facility recalls MANI TROCAR KIT 23G S - Product Usage: for use in injecting perfusate or aspirating out intraocular materials during op…

Recall date
October 27, 2020
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0557-2021
FDA classification
Class II
Brand / firm
Mani, Inc. - Kiyohara Facility
Sold / distributed
US Nationwide distribution in the state of MO.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

Get recall alerts

Free email alert whenever Mani, Inc. - Kiyohara Facility has a new recall — straight from official government data. Unsubscribe anytime.

More recalls from: Mani, Inc. - Kiyohara Facility