BEUDAMED
    FDA Enforcement Class II Ongoing

    Bard Mission Disposable Core Biopsy Instrument Kit: 16G x 10CM, REF: 1610MSK; 18G x 16CM, REF: 1816MSK

    Recall: Z-1260-2023 · Reported March 22, 2023

    Enforcement

    Recall Number
    Z-1260-2023
    Event ID
    91638
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Bard Peripheral Vascular Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 22, 2023
    Initiation Date
    February 28, 2023
    Classification Date
    March 16, 2023
    Address
    1625 W 3rd St Bldg 1, N/A, Tempe, AZ, 85281-2438, United States

    Description

    Bard Mission Disposable Core Biopsy Instrument Kit: 16G x 10CM, REF: 1610MSK; 18G x 16CM, REF: 1816MSK

    Reason

    The external diameter of the biopsy instrument is larger than the internal diameter of the coaxial needle, which could lead to: 1) Procedural delay, 2) Requirement of an additional device, 3), Needle tip breakage, if used despite incompatibility.

    Code Info

    REF/UDI-DI/Lot(Expiration Date): 1610MSK/00801741142567/1445630(11/28/2024), 1449980(12/28/2024), 1451134(1/28/2025); 1816MSK/00801741097065/1447510(12/28/2024), 1447511(12/28/2024), 1447512(12/28/2024), 1447513(12/28/2024), 1448118(12/28/2024), 1448119(12/28/2024), 1448120(12/28/2024), 1448121(12/28/2024), 1448743(12/28/2024), 1450413(12/28/2024), 1450414(12/28/2024), 1451075(1/28/2025), 1451076(1/28/2025), 1451621(1/28/2025), 1451622(1/28/2025), 1451625(1/28/2025), 1451626(1/28/2025), 1453516(1/28/2025), 1453517(1/28/2025), 1454295(1/28/2025), 1456850(2/28/2025), 1456856(2/28/2025), 1457030(2/28/2025)

    Distribution

    Worldwide Distribution: US (Nationwide) includes states of: FL, MD, OH, CO, PA, TX, NC, CA, ME, MO, NV, MI, IL, NY, VA, AZ, NH, LA, WI, KY, MA, WA, CT, SD, OK, DC, IA, AR, GA, NE, NM, IN, NJ, MN, PR, AL, AK, SC, KS, OR, ID, VT, MT, WV, ND, TN, MS, HI, WY, RI and OUS countries of: Canada, Korea, Thailand and Taiwan. OUS: AR, AU, BE, CA, CN, CO, HK, IN, JP, KR, TH, TW

    Quantity

    38,635