FDA recall Z-0557-2021

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 for recall

Dimensions of the Luer connector parts out of specification, may cause leakage of fluid and unintended disconnection during use

Distribution

US Nationwide distribution in the state of MO.

Key facts

Status

Terminated

Initiation date

2020-10-27

Report date

2020-12-16

Termination date

2021-08-11

Voluntary/Mandated

Voluntary: Firm initiated

Location

Utsunomiya, N/A, Japan

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0557-2021