BEUDAMED
    FDA Recall Terminated

    The Better-Bladder With 14" ID tubing, ITEM BB14, STERILE, Measure pressure noninvasively in the extracorporeal circuit and provide compliance in the venous line between the patient and the pump.

    Recall: Z-0057-2017 · Initiated July 1, 2016

    Recall

    Recall Number
    Z-0057-2017
    Event Number
    74614
    Firm
    Circulatory Technology Inc
    FEI Number
    1000522036
    Product Code
    DTN
    Status
    Terminated
    Root Cause
    Use error
    Initiated
    July 1, 2016
    Posted
    October 7, 2016
    Terminated
    April 14, 2017
    Address
    21 Singworth St, Oyster Bay, NY, 11771-3703

    Description

    The Better-Bladder With 14" ID tubing, ITEM BB14, STERILE, Measure pressure noninvasively in the extracorporeal circuit and provide compliance in the venous line between the patient and the pump.

    Reason

    Twisted or wrinkled balloon components which are considered a cosmetic defect by the firm.

    Action

    The firm, Circulatory Technology Inc., sent an "Urgent: Device Recall" letter dated July 1, 2016 and response forms to their customers via email. The letter described the product, problem and actions to be taken. The letter instructed customers to immediately inspect their inventory visually for units with wrinkled or twisted balloons and quarantine. Customers were also advised to complete and return the response form via email to [email protected]. Customers with questions are asked to contact Yehuda Tamari at (516) 624-2424, Monday to Friday, 9:00 AM - 7:00 PM, EST.

    Distribution

    US Nationwide Distribution to states of: AL, AR, CA, Washington, D.C., FL, GA, IA, IL, IN, KY, LA, MI, MS, NC, NJ, NY, OH, OK, PA, SC, TN, TX & VA.

    Quantity

    958 units