BEUDAMED
    FDA Enforcement Class II 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 · Reported November 12, 2014

    Enforcement

    Recall Number
    Z-0178-2015
    Event ID
    69535
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Dokitz NovoSci
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 12, 2014
    Initiation Date
    September 18, 2014
    Classification Date
    November 6, 2014
    Termination Date
    May 15, 2015
    Address
    2021 Airport Rd, N/A, Conroe, TX, 77301-3250, United States

    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.

    Code Info

    Model No. 321334-000, lot number 295424

    Distribution

    MO, TX, PA, IL, MD, UT

    Quantity

    240 units