BEUDAMED
    FDA Enforcement Class II Ongoing

    EchoTip¿ Ultra HD Endoscopic Ultrasound Access Needle, ECHO-HD-19-A, G52012

    Recall: Z-1832-2024 · Reported May 22, 2024

    Enforcement

    Recall Number
    Z-1832-2024
    Event ID
    94395
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Cook Medical Incorporated
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 22, 2024
    Initiation Date
    April 1, 2024
    Classification Date
    May 16, 2024
    Address
    400 N Daniels Way, N/A, Bloomington, IN, 47404-9155, United States

    Description

    EchoTip¿ Ultra HD Endoscopic Ultrasound Access Needle, ECHO-HD-19-A, G52012

    Reason

    Devices may contain elevated levels of bacterial endotoxin.

    Code Info

    Catalogue Number: ECHO-HD-19-A; GPN: G52012; UDI/DI: 00827002520127; Lot Numbers: C2145003 and C2144407.

    Distribution

    International distribution in the countries of Germany, Netherlands, Switzerland, United Kingdom.

    Quantity

    1 Unit OUS