BEUDAMED
    FDA Enforcement Class II Ongoing

    EkoSonic Kit 135cm, 12cm TZ The EkoSonic Endovascular Device is packaged as a kit that includes both the USC and IC components. They are placed into the respective trays and sealed in a Tyvek pouch. The sealed pouches are placed inside the kit carton (box) and the product labels.

    Recall: Z-1491-2022 · Reported August 10, 2022

    Enforcement

    Recall Number
    Z-1491-2022
    Event ID
    90528
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Boston Scientific Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    August 10, 2022
    Initiation Date
    May 25, 2022
    Classification Date
    August 1, 2022
    Address
    1 Scimed Pl, N/A, Maple Grove, MN, 55311-1565, United States

    Description

    EkoSonic Kit 135cm, 12cm TZ The EkoSonic Endovascular Device is packaged as a kit that includes both the USC and IC components. They are placed into the respective trays and sealed in a Tyvek pouch. The sealed pouches are placed inside the kit carton (box) and the product labels.

    Reason

    Product may be mislabeled.

    Code Info

    UPN: 500-56112 GTIN: 858593006264 Lot Numbers: 8035075263, 8035075264, 8035075265, 8035075266, 8035075267, 8035075268, 8035075269, 8035075270, 8035075271, 8035075272

    Distribution

    US distribution only - CA, CT, GA, IA, IL, IN, NY, OH, TX, WY

    Quantity

    10 units