BEUDAMED
    FDA Recall Terminated

    Bard Biopsy EnCor Probe, MRI, 10G Trocar Tip, REF number ECPMR0110G, packaged individually in sterile pouches, 5 pouches/carton, Single Use, Rx, Sterile.

    Recall: Z-1433-2020 · Initiated January 3, 2020

    Recall

    Recall Number
    Z-1433-2020
    Event Number
    84929
    Firm
    Bard Peripheral Vascular Inc
    FEI Number
    2020394
    Product Code
    KNW
    Status
    Terminated
    Root Cause
    Component change control
    Initiated
    January 3, 2020
    Terminated
    March 17, 2022
    Address
    1625 W 3rd St, Bldg 1, Tempe, AZ, 85281-2438

    Description

    Bard Biopsy EnCor Probe, MRI, 10G Trocar Tip, REF number ECPMR0110G, packaged individually in sterile pouches, 5 pouches/carton, Single Use, Rx, Sterile.

    Reason

    Lot numbers and products inadvertently not included in the scope of the previous recall. Original recall was conducted due to an increase in probe failures for leaks, suction issues, and failure to obtain samples.

    Action

    The recalling firm issued letters dated 1/3/2020 to each of the U.S. consignees via FedEx with proof of delivery notification. The letter identified the affected product, problem and actions to be taken. For questions call 1-800-321-4254 Option #5.

    Distribution

    Distribution was made to AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, MA, MD, MI, MN, MO, MS, NC, NJ, NY, OH, OK, OR, PA, SC, TX, VA, and WV. There was government distribution and no military distribution. Foreign distribution was made to Canada, Australia, Austria, Belgium, China, Czech Republic, Germany, France, Georgia, Greece, Hong Kong, Israel, Italy, Japan, Korea, Netherlands, New Zealand, Poland, Portugal, Russia, Saudi Arabia, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, and United Kingdom.

    Quantity

    2,050 units