BEUDAMED
    FDA Recall Terminated

    IBC FloProbe (Non-sterile), a disposable flow probe that is used as a component of the Medtronic Bio-Console System. The Medtronic Bio-Console System is intended for use in the monitoring of the extracorporeal cardiopulmonary bypass circuit blood flow rate during open heart surgery. part #3080N; packaged 10 per carton; International Biophysics Corp., Austin, TX.

    Recall: Z-1223-06 · Initiated April 22, 2005

    Recall

    Recall Number
    Z-1223-06
    Event Number
    35704
    Firm
    International Biophysics Corp
    FEI Number
    1000117854
    Product Code
    DPT
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 22, 2005
    Posted
    July 12, 2006
    Terminated
    July 18, 2006
    Address
    2101-2 E Saint Elmo, Ste 275, Austin, TX, 78744

    Description

    IBC FloProbe (Non-sterile), a disposable flow probe that is used as a component of the Medtronic Bio-Console System. The Medtronic Bio-Console System is intended for use in the monitoring of the extracorporeal cardiopulmonary bypass circuit blood flow rate during open heart surgery. part #3080N; packaged 10 per carton; International Biophysics Corp., Austin, TX.

    Reason

    Complaints received regarding the device's failure to zero out.

    Action

    Firm notified customers via e-mail and phone calls starting on 04/22/05.

    Distribution

    Nationwide. Product distributed to direct accounts located in CO and MA. No foreign consignees.

    Quantity

    7,502