BEUDAMED
    FDA Recall Open, Classified

    Bard Marquee Disposable Core Biopsy Instrument Kit: BARD MARQUEE KIT 12G X 10 CM, REF: MQK1210; BARD MARQUEE 12G X 10 CM, REF: MQ1210; BARD MARQUEE Kit 12G X 13 CM, REF: MQK1213; BARD MARQUEE 12G X 13 CM, REF: MQ1213

    Recall: Z-0467-2025 · Initiated September 30, 2024

    Recall

    Recall Number
    Z-0467-2025
    Event Number
    95491
    Firm
    Bard Peripheral Vascular Inc 1625 W 3rd St Bldg 1 850 W. Rio Salado Prkwy. Tempe AZ 85281-2438
    FEI Number
    2020394
    Product Code
    KNW
    Status
    Open, Classified
    Root Cause
    Process change control
    Initiated
    September 30, 2024
    Posted
    November 15, 2024

    Description

    Bard Marquee Disposable Core Biopsy Instrument Kit: BARD MARQUEE KIT 12G X 10 CM, REF: MQK1210; BARD MARQUEE 12G X 10 CM, REF: MQ1210; BARD MARQUEE Kit 12G X 13 CM, REF: MQK1213; BARD MARQUEE 12G X 13 CM, REF: MQ1213

    Reason

    Disposable biopsy instruments were potentially manufactured missing the backend notch retention feature on the needle that results in inadequate securing of the needle inside the device, which could lead to needle detachment and misplacement, which could lead to tissue damage and bleeding.

    Action

    On 9/30/24, removal notices were sent to customers who were asked to do the following: 1) Discontinue use of product listed in the letter, and immediately dispose of all affected product remaining in your possession in accordance with your local facility s process. 2) Share this notification with all users within your facility network of the product to ensure they are also aware of this field action. If the affected products have been distributed further, please share this notice to ensure that these entities are contacted and informed of the recall. 3) Complete and return the response form via email to [email protected] - If you purchased this product from a distributor, contact your distributor for further instructions and resolution. - Affected lots distributed from 05 April 2023 through 23 Aug 2024. If further assistance is required contact the firm: - North American Regional Complaint Center: 1-844-823-5433, Mon - Fri 8:00am and 5:00pm CT, [email protected] - Recall Related Questions: [email protected] On 1/15/2025, additional removal notices were mailed or emailed to distributors informing them of additional affected devices.

    Distribution

    Worldwide - US Nationwide including in the states of WA, LA, MN, PA, UT, SC, OK, KY, AZ, IL, TX, NJ, NY, FL, TN, IN, OH, NC, CO, VA, GA, MD, CA, AL, WI, MO, IA, CT, NE, MI, MS, NV, KS, OR, SD, ID, NH, RI, WY, AR, MA, DE, ND, NM, AK, PR and the countries of Portugal, Spain, South Africa, Greece, United Arab Emirates, United Kingdom, Sweden, Finland, Belgium, Korea, Australia, Canada.

    Quantity

    71,498