Z-0557-2021 Class II Terminated
FDA device recall Z-0557-2021 was initiated by Mani, Inc. - Kiyohara Facility on October 27, 2020 and is designated Class II. Reason for recall: Dimensions of the Luer connector parts out of specification, may cause leakage of fluid and unintended disconnection during use The recall status is terminated (terminated August 11, 2021). Affected quantity: 6 units (US).
Recall Details
- Product Type
- Devices
- Report Date
- December 16, 2020
- Initiation Date
- October 27, 2020
- Termination Date
- August 11, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6 units (US)
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
Distribution Pattern
US Nationwide distribution in the state of MO.
Code Information
Lot Codes: V180077300, Exp Date: 2020/10 and V200009500, EXp Date: 2022/03