BEUDAMED
    FDA Enforcement Class II Ongoing

    Brand Name: Q-Stop Product Name: Suture Retention Device Model/Catalog Number: QS Software Version: N/A Product Description: The DRS Vascular Q-Stop Suture Retention Appliance is a sterile, single-use, lightweight device made of biocompatible materials that can be easily installed within minutes to assist with venous access hemostasis. Component: No

    Recall: Z-2330-2025 · Reported August 27, 2025

    Enforcement

    Recall Number
    Z-2330-2025
    Event ID
    97128
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Drs Vascular, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    August 27, 2025
    Initiation Date
    May 16, 2025
    Classification Date
    August 15, 2025
    Address
    1914 Otoole Way, N/A, San Jose, CA, 95131-2237, United States

    Description

    Brand Name: Q-Stop Product Name: Suture Retention Device Model/Catalog Number: QS Software Version: N/A Product Description: The DRS Vascular Q-Stop Suture Retention Appliance is a sterile, single-use, lightweight device made of biocompatible materials that can be easily installed within minutes to assist with venous access hemostasis. Component: No

    Reason

    XXX

    Code Info

    Lot Code: 00860011629405 (6-pack) Unit of use: 10860011629402

    Distribution

    U.S. Nationwide distribution in the states of AR, CA, and NY.

    Quantity

    264