BEUDAMED
    FDA Enforcement Class II Terminated

    NES Reprocessed Visions PV .035 IVUS Catheter, Sterile. For use in the evaluation of vascular morphology in blood vessels of the peripheral vasculature by providing a crosssectional image of such vessels. NES Ref. No. R-88901

    Recall: Z-2334-2021 · Reported September 1, 2021

    Enforcement

    Recall Number
    Z-2334-2021
    Event ID
    88345
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Northeast Scientific Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    September 1, 2021
    Initiation Date
    April 26, 2021
    Classification Date
    August 23, 2021
    Termination Date
    March 9, 2022
    Address
    2142 Thomaston Ave, N/A, Waterbury, CT, 06704-1013, United States

    Description

    NES Reprocessed Visions PV .035 IVUS Catheter, Sterile. For use in the evaluation of vascular morphology in blood vessels of the peripheral vasculature by providing a crosssectional image of such vessels. NES Ref. No. R-88901

    Reason

    510k indicated one (1) reprocessing cycle, product not cleared for additional reprocessing cycles.

    Code Info

    Lots L0017886 through L0020553

    Distribution

    US Nationwide distribution in the states of CA, CT, FL, GA, IL, MA, NC, NJ, NY, TX.

    Quantity

    690 devices