BEUDAMED
    FDA Recall Open, Classified

    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 · Initiated May 16, 2025

    Recall

    Recall Number
    Z-2330-2025
    Event Number
    97128
    Firm
    Drs Vascular, Inc
    FEI Number
    3030564133
    Product Code
    KGS
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    May 16, 2025
    Posted
    August 15, 2025
    Address
    1914 Otoole Way, San Jose, CA, 95131-2237

    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

    Action

    On 05/29/2025, the firm sent via FedEx next day an "URGENT MEDICAL DEVICE RECALL" Letter to customers informing them that they are conducting a voluntary recall of the Q-Stop Suture Retention Device Model QS due to some devices are prone to premature cutting of the suture. Customers are instructed to return all Q-Strop Suture Retention Device. Any used devices should be sent back in a sealed container. For questions contact firm at 510-345-7233 or [email protected]

    Distribution

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

    Quantity

    264