BEUDAMED
    FDA Enforcement Class II Terminated

    Mammotome MammoStar Biopsy Site Identified, REF STAR1401

    Recall: Z-1041-2023 · Reported February 8, 2023

    Enforcement

    Recall Number
    Z-1041-2023
    Event ID
    91419
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Carbon Medical Technologies, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    February 8, 2023
    Initiation Date
    December 16, 2022
    Classification Date
    January 30, 2023
    Termination Date
    August 9, 2023
    Address
    1290 Hammond Rd, N/A, Saint Paul, MN, 55110-5867, United States

    Description

    Mammotome MammoStar Biopsy Site Identified, REF STAR1401

    Reason

    The label incorrectly identifies the product as STAR1401, a 1x3mm Barbell shaped marker pre-loaded in a 14 gauge needle, while the packaging contains STAR1402, a 1x5mm Tribell shaped marker pre-loaded in a 14 gauge needle.

    Code Info

    UDI/DI 00858015005431, Lot Number 2201011A

    Distribution

    US Nationwide distribution in the state of OHIO.

    Quantity

    550 devices