BEUDAMED
    FDA Enforcement Class II Ongoing

    MultiLab Series II ROODRA non-invasive vascular diagnostic device, Model Number 11986-0000-01

    Recall: Z-1195-2023 · Reported March 8, 2023

    Enforcement

    Recall Number
    Z-1195-2023
    Event ID
    91564
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Unetixs Vascular, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 8, 2023
    Initiation Date
    February 10, 2023
    Classification Date
    March 1, 2023
    Address
    333 Strawberry Field Rd Ste 11, N/A, Warwick, RI, 02886-2459, United States

    Description

    MultiLab Series II ROODRA non-invasive vascular diagnostic device, Model Number 11986-0000-01

    Reason

    The current luer fittings and adaptors allow for the possibility of the air line to be misconnected to an intravenous line, which may cause an air embolism.

    Code Info

    All Serial Numbers

    Distribution

    Worldwide distribution - US Nationwide and Global distribution.

    Quantity

    2000 units