BEUDAMED
    FDA Enforcement Class II Ongoing

    Biosense Webster Carto Vizigo Bi-Directional Guiding Sheath, 8.5F(Medium), REF D-1385-02-S, RX CE 2797, Sterile

    Recall: Z-1320-2023 · Reported April 12, 2023

    Enforcement

    Recall Number
    Z-1320-2023
    Event ID
    91797
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Biosense Webster, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 12, 2023
    Initiation Date
    February 21, 2023
    Classification Date
    March 31, 2023
    Address
    31 Technology Dr Ste 200, Irvine, CA, 92618-2302, United States

    Description

    Biosense Webster Carto Vizigo Bi-Directional Guiding Sheath, 8.5F(Medium), REF D-1385-02-S, RX CE 2797, Sterile

    Reason

    Incorrect labeling; specifically, the product name, lot number and product code on the carton label for Bi-Directional Guiding Sheaths does not match the inner label pouch

    Code Info

    Lot # 50000224; UDI (GTIN) : 10846835016277

    Distribution

    Worldwide distribution - US Nationwide distribution including the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, MA, MD, MI, MN, MO, MS, MT, NC, NJ, NV, NY, OH, OK, PA, SC, SD, TN, TX, UT, VA, WI. The country of Japan.

    Quantity

    316 units