BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-0817-2018 · Initiated September 22, 2017

    Recall

    Recall Number
    Z-0817-2018
    Event Number
    79196
    Firm
    Circulatory Technology Inc
    FEI Number
    1000522036
    Product Code
    DTN
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    September 22, 2017
    Posted
    March 1, 2018
    Terminated
    May 20, 2020
    Address
    21 Singworth St, Oyster Bay, NY, 11771-3703

    Description

    Better-Bladder cardiopulmonary bypass blood reservoir; Models: BB14 (individual, sterile, pouched) and BB14NS (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.

    Action

    The firm is requesting that consignees immediately inspect inventory, and quarantine all units having the aforementioned lots. These units must be returned to CTI. CTI will provide UPS shipping labels for returning the units and will provide replacements or credit for the returned units. Should the inventory consist of only the affected lots then, until the consignee receives replacement BB14s from an unaffected lot, the firm recommends using the BB14 from the affected lots only if, prior to its use, they pull on the pigtail of the Better-Bladder to test its bond integrity prior to its use. If the pigtail dislodges then return the unit for credit or replacement. The consignees should complete and return the enclosed response form via email to [email protected] as soon as possible.

    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

    840