BEUDAMED
    FDA Enforcement Class II Ongoing

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

    Recall: Z-1862-2021 · Reported June 23, 2021

    Enforcement

    Recall Number
    Z-1862-2021
    Event ID
    88000
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Circulatory Technology Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    June 23, 2021
    Initiation Date
    April 27, 2021
    Classification Date
    June 15, 2021
    Address
    21 Singworth St, Oyster Bay, NY, 11771-3703, United States

    Description

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

    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

    Lot Number: 5290-201001 UDI: (01)00851997007004(10)5290-201001(17)20231021(11)20201021

    Distribution

    US Nationwide distribution in the states of AL, AR, CA, DC, FL, GA, IN, MO, NC, PA, SC, TX.

    Quantity

    147 units