FDA Device recall Z-0557-2021
MANI TROCAR KIT 23G S - Product Usage: for use in injecting perfusate or aspirating out intraocular materials during ophthalmic surgery, Re…
- FDA Device
- Class II
- terminated
- Published 2020-12-16
On 2020-12-16 the FDA classified a Class II recall of MANI TROCAR KIT 23G S - Product Usage: for use in injecting perfusate or aspirating out intraocular materials during ophthalmic surgery, Re… by Mani Kiyohara Facility, citing dimensions of the Luer connector parts out of specification, may cause leakage of fluid and unintended disconnection during use.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0557-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-10-27 |
| Published | 2020-12-16 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Mani Kiyohara Facility |
| Distribution | US |
Product
MANI TROCAR KIT 23G S - Product Usage: for use in injecting perfusate or aspirating out intraocular materials during ophthalmic surgery, Ref: MTK 23S
Reason
Dimensions of the Luer connector parts out of specification, may cause leakage of fluid and unintended disconnection during use
Identifiers
| code_info | Lot Codes: V180077300, Exp Date: 2020/10 and V200009500, EXp Date: 2022/03 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0557-2021%22
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