BEUDAMED
    FDA Enforcement Class II Terminated

    Bard TruGuide Disposable Coaxial Biopsy Needle  Mixed Product Part Number C1816B 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-2547-2016 · Reported August 24, 2016

    Enforcement

    Recall Number
    Z-2547-2016
    Event ID
    74663
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Bard Peripheral Vascular Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 24, 2016
    Initiation Date
    July 6, 2016
    Classification Date
    August 16, 2016
    Termination Date
    November 17, 2016
    Address
    1625 W 3rd St, N/A, Tempe, AZ, 85281-2438, United States

    Description

    Bard TruGuide Disposable Coaxial Biopsy Needle  Mixed Product Part Number C1816B 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

    May contain two trocar tip stylets with coaxials or two blunt tip stylets instead of one of each.

    Code Info

    Lot Number: REZK0479

    Distribution

    Nationwide Distribution to the following; CA, LA, VA, IA, AR, SC, PA, MA, IL, MO. Foreign distribution to the following; Canada, Belgium, Australia, Taiwan, China, Argentina.

    Quantity

    1250 units