UroLift System REF UL400-4, QTY 4 Urolfit System with Handle Release Tool
Reported: August 10, 2022 Initiated: June 24, 2022 #Z-1502-2022
Product Description
UroLift System REF UL400-4, QTY 4 Urolfit System with Handle Release Tool
Reason for Recall
There is the potential that during implant deployment, the device may not properly deliver a implant.
Details
- Recalling Firm
- Neotract Inc
- Units Affected
- 18,722 systems
- Distribution
- 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
- Location
- Pleasanton, CA
Frequently Asked Questions
What product was recalled? ▼
UroLift System REF UL400-4, QTY 4 Urolfit System with Handle Release Tool. Recalled by Neotract Inc. Units affected: 18,722 systems.
Why was this product recalled? ▼
There is the potential that during implant deployment, the device may not properly deliver a implant.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 10, 2022. Severity: Moderate. Recall number: Z-1502-2022.
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