BEUDAMED
    FDA Enforcement Class II Terminated

    BNX Fine Need Aspiration System (19GA); Material/Part #: DSN-19-01

    Recall: Z-1472-2017 · Reported March 22, 2017

    Enforcement

    Recall Number
    Z-1472-2017
    Event ID
    76497
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medtronic
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 22, 2017
    Initiation Date
    February 8, 2017
    Classification Date
    March 15, 2017
    Termination Date
    July 18, 2019
    Address
    60 Middletown Ave, N/A, North Haven, CT, 06473-3908, United States

    Description

    BNX Fine Need Aspiration System (19GA); Material/Part #: DSN-19-01

    Reason

    Handle may break during use.

    Code Info

    Lot Number: B000000176, B000000181

    Distribution

    US Distribution to AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, WA, WI; and countries of DK and DE

    Quantity

    1,096 Units (total for all products)