BEUDAMED
    FDA Recall Open, Classified

    Bard Mission Disposable Core Biopsy Instrument Kit (REF/Name): 1410MSK/ Mission Kit 14G x 10CM; 1416MSK/ Mission Kit 14G x 16CM; 1610MSK/ Mission Kit 16G x 10CM; 1616MSK/ Mission Kit 16G x 16CM; 1810MSK/ Mission Kit 18G x 10CM; 1816MSK/ Mission Kit 18G x 16CM; 1820MSK/ Mission Kit 18G x 20CM; 1825MSK/ Mission Kit 18G x 25CM; 2010MSK/ Mission Kit 20G x 10CM; 2016MSK/ Mission Kit 20G x 16CM; 2020MSK/ Mission Kit 20G x 20CM

    Recall: Z-0643-2024 · Initiated November 8, 2023

    Recall

    Recall Number
    Z-0643-2024
    Event Number
    93578
    Firm
    Bard Peripheral Vascular Inc
    FEI Number
    2020394
    Product Code
    KNW
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    November 8, 2023
    Posted
    January 5, 2024
    Address
    1625 W 3rd St, Bldg 1, Tempe, AZ, 85281-2438

    Description

    Bard Mission Disposable Core Biopsy Instrument Kit (REF/Name): 1410MSK/ Mission Kit 14G x 10CM; 1416MSK/ Mission Kit 14G x 16CM; 1610MSK/ Mission Kit 16G x 10CM; 1616MSK/ Mission Kit 16G x 16CM; 1810MSK/ Mission Kit 18G x 10CM; 1816MSK/ Mission Kit 18G x 16CM; 1820MSK/ Mission Kit 18G x 20CM; 1825MSK/ Mission Kit 18G x 25CM; 2010MSK/ Mission Kit 20G x 10CM; 2016MSK/ Mission Kit 20G x 16CM; 2020MSK/ Mission Kit 20G x 20CM

    Reason

    The internal diameter of the coaxial cannula may be smaller or larger than the external diameter of the biopsy needle, and the length of the cannula may exceed the stated length on the label. As a result, the biopsy needle may not fit properly into the coaxial cannula, preventing access to the target tissue, which could lead to tissue injury, longer and repeat procedures.

    Action

    On 11/8/23, recall notices were distributed to customers and distributors who were asked to do the following: 1) Discontinue use of affected product, 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 recall. If you purchased this product from a distributor, contact your distributor for further instructions and credit resolution. - Distributors were asked to Identify all customers within your distribution network that purchased any affected product as defined in this notification. Provide a copy of the attached customer letter to all customers to advise them of this expanded field action notification. 3) Complete and return the attached Customer Response Form via email to [email protected] Customers requiring additional assistance can contact the firm's North American Regional Complaint Center by phone: 1-844-823-5433, say "recall" when prompted M-F 8am - 5pm CT, or via email: [email protected]

    Distribution

    Worldwide - US Nationwide distribution including in the states of PR, IL, MA, GA, KY, CA, TX, PA, IA, MN, NH, MD, FL, ID, IN, AL, VA, CO, WI, NY, NV, OK, OH, WA, MI, MS, AZ, HI, SD, NJ, NE, MT, NC, DC, CT, WY, UT, TN, LA, NM, SC, VT, MO, ME, AR, OR, KS, RI, AK, WV, DE, ND, PR, GU and the countries of CA, BE, AU, KR, SG, CN, TH, HK, VI, VN, AR, JP, CL, IN, TW, CO, MX, DO, BR, BD, MM, PK, NP, PA.

    Quantity

    1,243,937