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

    FDA Recall
    Terminated ·Circulatory Technology Inc·Product code DTN·March 3, 2016

    The Bigger-Better-Bladder, TM 2 With 3/8"ID tubing, 72" long tubing, ITEM BBB38-72 A device that isolates pressure tranducers from blood contact when measurements of blood pressure in extracorporeal circuits are made during short and long term procedures. The pressure signal can be used to control pump speed. It is also used as an inline reservoir to provide compliance in the circuit during short and long term procedures. Measures pressure noninvasively in the extracorporeal circuit and provide compliance in the venous line between the patient and the pump.

    FDA Recall
    Terminated ·Circulatory Technology Inc·Product code DTN·July 1, 2016

    The Bigger Better-Bladder, Catalog Number BBB38 (with 3/8 inch ID tubing), Sterile, Single use only --- Manufactured for: Circulatory Technology Inc., 21 Singworth Street, Oyster Bay, 11771 (516) 624-2424 --- 510 (k) 981284.

    FDA Recall
    Terminated ·Circulatory Technology Inc·Product code DTN·June 3, 2009

    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.

    FDA Recall
    Terminated ·Circulatory Technology Inc·Product code DTN·July 1, 2016

    Better-Bladder cardiopulmonary bypass blood reservoir; Models: BB14 (individual, sterile, pouched) and BB14NS (sold bulk to kit manufacturers)

    FDA Recall
    Terminated ·Circulatory Technology Inc·Product code DTN·September 22, 2017

    **Recall Expanded to add these models: Bigger Better-Bladder cardiopulmonary bypass blood reservoir; Models: BBB38 (individual, sterile, pouched) and BBB38NS (sold bulk to kit manufacturers)

    FDA Recall
    Terminated ·Circulatory Technology Inc·Product code DTN·September 22, 2017

    The Better-Bladder (BB), part of extracorporeal membrane oxygenation (ECMO) cardiopulmonary bypass circuits. Model: BB14

    FDA Recall
    Open, Classified ·Circulatory Technology Inc.·Product code DTN·April 27, 2021