Neotract Inc recalls UroLift System REF UL400-4, QTY 4 Urolfit System with Handle Release Tool

Recall date

June 24, 2022

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1502-2022

FDA classification

Class II

Brand / firm

Neotract Inc

Sold / distributed

US: AK AL AR AZ CA CO CT DC DE FL GA IA IL IN KS KY LA MA MD ME MI MN MO MS MT NC ND NE NH NJ NM NY OH OK PA RI SC SD TN TX UT VA VT WI WV OUS: None

Why it was recalled

There is the potential that during implant deployment, the device may not properly deliver a implant.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

UroLift System REF UL400-4, QTY 4 Urolfit System with Handle Release Tool