BEUDAMED
    FDA Recall 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 · Initiated May 2, 2019

    Recall

    Recall Number
    Z-2214-2019
    Event Number
    83303
    Firm
    Bard Peripheral Vascular Inc
    FEI Number
    2020394
    Product Code
    KNW
    Status
    Terminated
    Root Cause
    Component change control
    Initiated
    May 2, 2019
    Terminated
    March 3, 2022
    Address
    1625 W 3rd St, Bldg 1, Tempe, AZ, 85281-2438

    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.

    Action

    The recalling firm issued letters dated 4/19/2019 via FedEx on 4/19/2019 with proof of delivery to the U.S. customers. The letters sent to foreign countries vary depending on the format required for the country.

    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