UroLift System REF UL400-4, QTY 4 Urolfit System with Handle Release Tool
Summary
The FDA issued a Class II for UroLift System REF UL400-4, QTY 4 Urolfit System with Handle Release Tool by Neotract Inc. Reason: There is the potential that during implant deployment, the device may not properly deliver a implant..
Details
Source
Device Recall
External ID
Z-1502-2022
Action Date
2022-08-10
Status
Ongoing
Category
device
Product Description
UroLift System REF UL400-4, QTY 4 Urolfit System with Handle Release Tool
Lot/Code Info: UDI/DI: 00814932020049 & 00814932020001; Lot #s: 73M2100393 73A2200670 73M2100394 73A2200671 73M2100395 73A2200672 73A2200012 73A2200673 73A2200013 73A2200674 73A2200014 73A2200832 73A2200221 73A2200841 73A2200222 73A2200859 73A2200223 73A2200905 73A2200224 73B2200116 73A2200225 73B2200466 73A2200226 73C2200567 73A2200473 New Lots added as of 08/01/2022: 73A2200834, 73C2200911, and 73C2201163
Quantity Affected: 18,722 systems
Reason for Recall
There is the potential that during implant deployment, the device may not properly deliver a implant.
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
Type: Voluntary: Firm initiated
Recall Initiated: 2022-06-24
Company
Pleasanton, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 97 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Neotract Inc has 3 FDA actions in our database, including 1 recall and 2 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Neotract Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Neotract Inc have FDA actions?
Neotract Inc has 3 FDA actions in our database, including 1 recall and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1502-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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