BEUDAMED
    FDA Enforcement Class II Terminated

    EnCor Breast Biopsy Probes, packaged individually in sterile pouches, 5 pouches/carton, single use, Rx, catalog/REF number 7GV Upright (Vertical) - REF ECP017GV. Product Usage: Indicated for use in acquiring tissue for diagnosing breast abnormalities.

    Recall: Z-2214-2019 · Reported August 14, 2019

    Enforcement

    Recall Number
    Z-2214-2019
    Event ID
    83303
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Bard Peripheral Vascular Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 14, 2019
    Initiation Date
    May 2, 2019
    Classification Date
    August 7, 2019
    Termination Date
    March 3, 2022
    Address
    1625 W 3rd St Bldg 1, N/A, Tempe, AZ, 85281-2438, United States

    Description

    EnCor Breast Biopsy Probes, packaged individually in sterile pouches, 5 pouches/carton, single use, Rx, catalog/REF number 7GV Upright (Vertical) - REF ECP017GV. Product Usage: Indicated for use in acquiring tissue for diagnosing breast abnormalities.

    Reason

    There has been an increase in complaints related to leaks, suction issues, and failure to obtain samples while using the product.

    Code Info

    Lot numbers VTCV0414, VTCW0469, VTCW0470, VTCY0566, VTCZ0640, VTCZ0648, and VTCZ0649.

    Distribution

    Worldwide distribution - US Nationwide distribution, including Puerto Rico. There was government and foreign distribution and no military distribution. Foreign distribution was made to Canada, Algeria, Australia, Austria, Belgium, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Egypt, Finland, France, Georgia, Germany, Gibraltar, Greece, Guadeloupe, Hungary, Iceland, India, Ireland, Italy, Japan, Korea, Kuwait, Luxembourg, Malaysia, Martinique, Monaco, Netherlands, New Zealand, Norway, Poland, Portugal, Qatar, Reunion, Russia, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom, and Viet Nam.

    Quantity

    12,833 units