BEUDAMED
    FDA Recall Terminated

    Cardiopulmonary bypass connector; P/N: 321334-000 DESC: CONNECTOR, 3/8 X 3/8 X 1/2 CLEAR PAY LOT: 295424 STERILE Expiration May 2019 Manufacturing Date May 2014

    Recall: Z-0178-2015 · Initiated September 18, 2014

    Recall

    Recall Number
    Z-0178-2015
    Event Number
    69535
    Firm
    Dokitz NovoSci
    FEI Number
    1625519
    Product Code
    DTL
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    September 18, 2014
    Posted
    November 6, 2014
    Terminated
    May 15, 2015
    Address
    2021 Airport Rd, Conroe, TX, 77301-3250

    Description

    Cardiopulmonary bypass connector; P/N: 321334-000 DESC: CONNECTOR, 3/8 X 3/8 X 1/2 CLEAR PAY LOT: 295424 STERILE Expiration May 2019 Manufacturing Date May 2014

    Reason

    The single leg of the PAY connector has been observed to become detached.

    Action

    The recalling firm notified the affected customers via letter and requested the affected lot be returned to NovoSci.

    Distribution

    MO, TX, PA, IL, MD, UT

    Quantity

    240 units