Device product
MANI TROCAR KIT 23G S - Product Usage: for use in injecting perfusate or aspirating out intraocular materials during ophthalmic surgery, Ref: MTK 23S
Z-0557-2021
Product summary
- Event
- Event 86873
- Status
- Terminated
- Classification
- Class II
- Quantity
- 6 units (US)
- Official record key
device-enforcement:Z-0557-2021
Official wording
Reason: Dimensions of the Luer connector parts out of specification, may cause leakage of fluid and unintended disconnection during use
Code information: Lot Codes: V180077300, Exp Date: 2020/10 and V200009500, EXp Date: 2022/03
Distribution pattern: US Nationwide distribution in the state of MO.
Derived failure modes
-
Potency or specification failure
out of specification