BEUDAMED
    FDA Recall Terminated

    Bigger-Better-Bladder With 3/8" ID tubing, ITEM BBB38

    Recall: Z-2050-2016 · Initiated March 3, 2016

    Recall

    Recall Number
    Z-2050-2016
    Event Number
    73608
    Firm
    Circulatory Technology Inc
    FEI Number
    1000522036
    Product Code
    DTN
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    March 3, 2016
    Terminated
    April 20, 2017
    Address
    21 Singworth St, Oyster Bay, NY, 11771-3703

    Description

    Bigger-Better-Bladder With 3/8" ID tubing, ITEM BBB38

    Reason

    The seal between the balloon and the housing may leak.

    Action

    Circulatory Technology Inc. sent an Urgent Product Recall notices dated March 3, 2016, to their customers via email. Circulatory Technology Inc. has identified this action as a voluntary recall, however they did not withdraw the product from the market. Instead, Circulatory Technology Inc. has advised customers to check the integrity of the seal between both the inlet and outlet tube and the housing as per the Instructions For Use. In addition, for this lot, Circulatory Technology Inc. recommends that you bend the inlet as well as the outlet tube away from the housing before conducting the leak test. There should be no visible separation between the tubing and the housing. Customers with questions can call 516-624-2424.

    Distribution

    US Distribution to the states of: CA, IN, MI, NY, PA, TX & VA

    Quantity

    72 units