BEUDAMED
    FDA Enforcement Class II Terminated

    Bard TruGuide Disposable Coaxial Biopsy Needle Product Usage: The TruGuide Disposable Coaxial Biopsy Needles are intended for use as a guiding needle in obtaining core biopsy samples from soft tissue such as liver, kidney, spleen, lymph nodes and various soft tissue lesions.

    Recall: Z-1396-2016 · Reported April 20, 2016

    Enforcement

    Recall Number
    Z-1396-2016
    Event ID
    73249
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Bard Peripheral Vascular Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 20, 2016
    Initiation Date
    February 4, 2016
    Classification Date
    April 14, 2016
    Termination Date
    August 3, 2016
    Address
    1625 W 3rd St, N/A, Tempe, AZ, 85281-2438, United States

    Description

    Bard TruGuide Disposable Coaxial Biopsy Needle Product Usage: The TruGuide Disposable Coaxial Biopsy Needles are intended for use as a guiding needle in obtaining core biopsy samples from soft tissue such as liver, kidney, spleen, lymph nodes and various soft tissue lesions.

    Reason

    Bard Peripheral Vascular, Inc. is recalling Bard TruGuide Disposable Coaxial Biopsy Needles because they have the potential to have the incorrect sized blunt tip stylet within its packaging that will not pass through the coaxial.

    Code Info

    Part Number: C2016B Lot Numbers: REWL0924, REXA1695, REXB1529, REXC1632

    Distribution

    U.S. distribution to the following; SC, CO, MT, PA, MA, TX, MI, VA OH, CA, GA, WA, MO, KS, TN, IA, FL, NV, PR. Foreign distribution to the following; Canada, Austria, Brazil, China, Cyprus, Holland, France, Spain, Netherlands, Norway, Portugal, UK.

    Quantity

    2320 units