BEUDAMED
    FDA Enforcement Class II Terminated

    **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)

    Recall: Z-1171-2018 · Reported March 7, 2018

    Enforcement

    Recall Number
    Z-1171-2018
    Event ID
    79196
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Circulatory Technology Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    March 7, 2018
    Initiation Date
    September 22, 2017
    Classification Date
    March 23, 2018
    Termination Date
    May 20, 2020
    Address
    21 Singworth St, N/A, Oyster Bay, NY, 11771-3703, United States

    Description

    **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)

    Reason

    The device is used as part of extracorporeal membrane oxygenation (ECMO) cardiopulmonary bypass circuits and may collapse during use which can increase resistance to flow in the venous line and cause a drop in circuit blood flow.

    Code Info

    **Recall expanded to add these models: BBB38, Lot Number: 5300-S19813; BBB38NS, Lot Number: 1707-1 and 170903

    Distribution

    **Requested update** Distributed in 19 states: AL, AR, CA, FL, GA, IL, IN, KY, MD, MO, NJ, NY, OH, OR, PA, TN, TX, VA, WA, and the District of Columbia.

    Quantity

    410