BEUDAMED
    FDA Adverse Event Other Summary report: N

    FLUID ADMINISTRATION SETS

    MDR report key: 1029714 · Received April 17, 2008

    Report

    Report Number
    1721504-2008-00021
    Event Type
    Other
    Date Received
    April 17, 2008
    Report Date
    April 7, 2008
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    FPA
    Removal / Correction Number
    1721504-04/07/08-004-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION CONCLUSIONS - OTHER- MERIT MEDICAL HAS DISCOVERED THAT CERTAIN FLUID ADMINISTRATION SETS WERE ASSEMBLED WITH MIXED LOTS OF FILTERED AND NON-FILTERED DRIP CHAMBERS. THIS PRESENTS A RISK TO END USERS REQUIRING FILTRATION OF FLUIDS FOR INTRAVASCULAR INFUSION. PLEASE NOTE THAT THERE HAVE BEEN NO ADVERSE EVENTS REPORTED THAT ARE ASSOCIATED WITH THIS RECALL.

    Description of Event or Problem · 1

    THIS IS TO INFORM YOU THAT MERIT MEDICAL SYSTEMS, INC. IS VOLUNTARILY RECALLING SPECIFIC LOTS OF FLUID ADMINISTRATION SETS (FAS) MANUFACTURED BY MERIT MEDICAL SYSTEMS, INC. PLEASE NOTE THAT THERE HAVE BEEN NO ADVERSE EVENTS REPORTED THAT ARE ASSOCIATED WITH THIS RECALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLUID ADMINISTRATION SETS SET, ADMINISTRATION, INTRAVASCULAR FPA MERIT MEDICAL SYSTEMS, INC. F605310

    Patients

    Seq Age Sex Outcome Treatment
    1