BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-1502-2022 · Initiated June 24, 2022

    Recall

    Recall Number
    Z-1502-2022
    Event Number
    90548
    Firm
    Neotract Inc
    FEI Number
    3005791775
    Product Code
    PEW
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    June 24, 2022
    Posted
    August 5, 2022
    Address
    4155 Hopyard Rd, Pleasanton, CA, 94588-8534

    Description

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

    Reason

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

    Action

    Between the dates of June 28-29, 2022, NeoTract, Inc. (a subsidiary of Teleflex Inc.) issued a "Urgent Medical Device Recall" notification to affected consignees via UPS. On July 29,2022 NeoTract, Inc. sent an updated recall notification for additional lots that were affected. NeoTract asked consignees to take the following actions: 1. If you have affected stock: a. Immediately discontinue use and quarantine any products with the lot numbers listed above, so that the affected products can be returned to Teleflex. Lot numbers are printed on the product shelf carton and Tyvek labels (refer to attached appendix demonstrating how you can locate the lot numbers and part catalog numbers for these products) b. Please return the affected products as follows as soon as possible: c. Complete the enclosed Recall Acknowledgement Form and email back to [email protected]. This will allow us to document the number of affected products you have on hand for return. A customer service representative will issue you a Return Goods Authorization (RGA) Number and will provide instructions for returning the products to Teleflex. d. Attach the RGA Number to the affected product and follow the shipping instructions provided by Teleflex customer service. 2. If you have no affected stock: a. Please complete the enclosed Recall Acknowledgement Form and email back to [email protected]. This will allow us to document your receipt of this letter. 3. Adverse reactions or quality problems experienced with the use of this product should be reported to Teleflex Customer Service at (866) 396-2111 or may also be reported to the FDA s MedWatch Adverse Event Reporting program either online at www.fda.gov/medwatch/report.htm, by fax to 1-800-FDA (332)-0178 or by phone, 1- 800-FDA (332)-1088.

    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

    Quantity

    18,722 systems