BEUDAMED
    FDA Enforcement Class II Terminated

    Velocity" Biopsy Valve, 25 units per box, Product Usage: The disposable Velocity biopsy valve is used to cover the opening of the biopsy inlet port of a flexible gastrointestinal endoscope. The Velocity biopsy valve provides access for endoscopic device passage and exchange, helps maintain insufflation, and minimizes leakage of biomaterial from the accessory port throughout the gastrointestinal endoscopic procedure. The Velocity biopsy valve provides a connection for irrigation through the Velocity irrigation pump.

    Recall: Z-1943-2015 · Reported July 8, 2015

    Enforcement

    Recall Number
    Z-1943-2015
    Event ID
    71336
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    US Endoscopy Group Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 8, 2015
    Initiation Date
    February 17, 2015
    Classification Date
    June 30, 2015
    Termination Date
    September 21, 2015
    Address
    5976 Heisley Rd, Mentor, OH, 44060-1873, United States

    Description

    Velocity" Biopsy Valve, 25 units per box, Product Usage: The disposable Velocity biopsy valve is used to cover the opening of the biopsy inlet port of a flexible gastrointestinal endoscope. The Velocity biopsy valve provides access for endoscopic device passage and exchange, helps maintain insufflation, and minimizes leakage of biomaterial from the accessory port throughout the gastrointestinal endoscopic procedure. The Velocity biopsy valve provides a connection for irrigation through the Velocity irrigation pump.

    Reason

    The company has received reports of structural non conformance at the connection between the valve body and the irrigation tube, resulting in separation of the components during use.

    Code Info

    M/N: 00711140; Lot #'s: 1401267, 1404503, 1408953, 1413362, 1417521, 1420739, 1422288, 1422747, 1424014, and 1500443.

    Distribution

    Worldwide Distribution - US Nationwide in the states of: CA, CO, IA, MA, OH, TX & WV and the countries of: Brazil, Costa Rica, Croatia, Czech Republic, Egypt, France, Germany, India, Indonesia, Italy, Latvia, Lithuania, Philippines, Poland, Romania, Russian Federation, Slovenia & South Africa.

    Quantity

    2,173 units