BEUDAMED
    FDA Enforcement Class II Ongoing

    Aquas PowerFlow Tube Set - Product Usage: The device delivers sterile irrigation fluids to surgical sites during laparoscopic procedures and to evacuate blood, tissue debris, and smoke from the surgical site

    Recall: Z-0094-2021 · Reported October 21, 2020

    Enforcement

    Recall Number
    Z-0094-2021
    Event ID
    86173
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Genicon, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    October 21, 2020
    Initiation Date
    August 25, 2020
    Classification Date
    October 9, 2020
    Address
    6869 Stapoint Ct Ste 112, N/A, Winter Park, FL, 32792-6603, United States

    Description

    Aquas PowerFlow Tube Set - Product Usage: The device delivers sterile irrigation fluids to surgical sites during laparoscopic procedures and to evacuate blood, tissue debris, and smoke from the surgical site

    Reason

    The product design incorporating a motor driven impeller pump powered by one 9V alkaline battery inside the hand-piece did not receive proper premarket clearance from US FDA and lacks a 510(k).

    Code Info

    Model # 720-005-000 (BPSI SET WITH NO PROBE); Lot # I9214-C Model # 720-005-001 (BPSI SET 8 VENT PROBE); Lot Numbers: I8881-D I8873-D I9057-D I9058-D I9209-D I9213-D I9227-D I9235-D I9236-D I9237-D I9278-D I9280-D I9282-D I9283-D I9299-D I9309-D I9322-D I9324-D I9356-D I9358-D I9360-D I9361-D I9362-D I9363-D I9364-D I9365-D

    Distribution

    Worldwide distribution - US Nationwide distribution including in the states of AL, AZ, CA, CO, FL, IA, IL, IN, MA, MI, MO, NC, OH, TN, VA, WA, WI and the countries of ECUADOR, HONG KONG, QATAR, SAUDI ARABIA, UAE (Dubai), JORDAN, KUWAIT, SOUTH AFRICA.

    Quantity

    10808 units