BEUDAMED
    FDA Enforcement Class II Terminated

    BARD Biopsy Systems UltraClip Dual Trigger breast tissue marker. Intended for use to attach to soft breast tissue at the surgical site during an open surgical breast biopsy.

    Recall: Z-1524-2013 · Reported June 19, 2013

    Enforcement

    Recall Number
    Z-1524-2013
    Event ID
    65046
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Bard Peripheral Vascular Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    June 19, 2013
    Initiation Date
    April 16, 2013
    Classification Date
    June 8, 2013
    Termination Date
    January 30, 2014
    Address
    1625 W 3rd St Ste 109, N/A, Tempe, AZ, 85281-2438, United States

    Description

    BARD Biopsy Systems UltraClip Dual Trigger breast tissue marker. Intended for use to attach to soft breast tissue at the surgical site during an open surgical breast biopsy.

    Reason

    Bard Peripheral Vascular (BPV) has confirmed that some devices with the recalled product code / lot number combination may have the metal tissue marker separated from the needle prior to use.

    Code Info

    Affected Product Lots with the following Product Code and Lot Number combinations. Product Code 864017D 864017D 864017D 864017D 864017D 864017D 864017D 864017DL Lot Number HUWI1522 HUWI1941 HUWI1942 HUWI1943 HUWJ1851 HUWJ1852 HUWK0350 HUWJ1610

    Distribution

    Worldwide Distribution: USA Nationwide and Internationally to Europe.

    Quantity

    3,085