BEUDAMED
    FDA Recall Terminated

    Trio Monitor. Cardiac Monitor (including cardiotachometer and rate alarm).

    Recall: Z-1483-04 · Initiated July 28, 2004

    Recall

    Recall Number
    Z-1483-04
    Event Number
    29941
    Firm
    Datascope Corp
    FEI Number
    2221819
    Product Code
    DRT
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 28, 2004
    Posted
    September 21, 2004
    Terminated
    November 22, 2004
    Address
    800 MacArthur Blvd, Mahwah, NJ, 07430-2001

    Description

    Trio Monitor. Cardiac Monitor (including cardiotachometer and rate alarm).

    Reason

    The Trio Monitor has latex feet. It is not labeled per 21 CFR801.437 to indicate that it contains latex.

    Action

    On July 28, 2004, the firm sent out a Urgent Product Field Correction via FedEx to their customers. Enclosed with this letter was the replacement feet, an Instruction form and a field correction completion form.

    Distribution

    Product was shipped to hospitals and medical clinics nationwide.

    Quantity

    146