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
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