BEUDAMED
    FDA Recall Terminated

    Mammotome MammoStar Biopsy Site Identified, REF STAR1401

    Recall: Z-1041-2023 · Initiated December 16, 2022

    Recall

    Recall Number
    Z-1041-2023
    Event Number
    91419
    Firm
    Carbon Medical Technologies, Inc.
    FEI Number
    3002619738
    Product Code
    NEU
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    December 16, 2022
    Posted
    January 30, 2023
    Terminated
    August 9, 2023
    Address
    1290 Hammond Rd, Saint Paul, MN, 55110-5867

    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.

    Action

    Carbon Medical Technologies sent an IMPORTANT: MEDICAL DEVICE RECALL notice by email to its sole consignee on 12/16/2022. The notice explained the issue and requested that the consignee perform the following actions: "Immediately examine your inventory and quarantine product subject to recall. In addition, if you may have further distributed this product, please identify you customers and notify them at once of this product recall." "Affected product should be returned to: Regulatory Affairs, Carbon Medical Technologies, Inc., 1290 Hammond Road, St. Paul, MN 55110-5959" "If you have any question, comments, or concerns please contact Customer Support at +1 888-207-2062. You may also email [email protected]."

    Distribution

    US Nationwide distribution in the state of OHIO.

    Quantity

    550 devices