Recall Z-0557-2021— Mani, Inc. - Kiyohara Facility
Class II · Terminated
Class II FDA medical device recall by Mani, Inc. - Kiyohara Facility, initiated 2020-10-27, terminated 2021-08-11. FDA's recall record names no specific 510(k) clearance for this event. 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.
- Recalling firm
- Mani, Inc. - Kiyohara Facility
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-10-27
- Terminated
- 2021-08-11
- Firm location
- Utsunomiya, N/A, Japan
Product description
MANI TROCAR KIT 23G S - Product Usage: for use in injecting perfusate or aspirating out intraocular materials during ophthalmic surgery, Ref: MTK 23S
Reason for recall
Dimensions of the Luer connector parts out of specification, may cause leakage of fluid and unintended disconnection during use
Data sourced from openFDA. This site is unofficial and independent of the FDA.