BEUDAMED
    FDA Recall Terminated

    Fountain Infusion System, 4F, REF IS4-90-50, Sterile, Merit Medical Systems, Inc., South Jordan, Utah 84095. Continuous flush catheter intended to administer infusions of various therapeutic solutions into the peripheral vasculature of a patient.

    Recall: Z-2107-2008 · Initiated May 14, 2008

    Recall

    Recall Number
    Z-2107-2008
    Event Number
    48445
    Firm
    Merit Medical Systems, Inc.
    FEI Number
    1721504
    Product Code
    KRA
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    May 14, 2008
    Posted
    September 11, 2008
    Terminated
    March 8, 2010
    Address
    1600 Merit Pkwy South, Jordan, UT, 84095

    Description

    Fountain Infusion System, 4F, REF IS4-90-50, Sterile, Merit Medical Systems, Inc., South Jordan, Utah 84095. Continuous flush catheter intended to administer infusions of various therapeutic solutions into the peripheral vasculature of a patient.

    Reason

    Catheters were packaged with occluding wires that were too long for the catheter. Potential for wire to not occlude the catheter appropriately, allowing the wire to exit the tip of the catheter further than intended, posing a potential risk of physical damage to the patient.

    Action

    Merit's six sales reps for the six hospital consignees were notified by letter on 05/14/2008. They were instructed to contact the hospitals and have them immediately quarantine any affected product for return to Merit. If you have any questions please contact Jackie Preece, Customer Service at 1-201-253-1600.

    Distribution

    Class II Recall - Nationwide Distribution --- including states of MA, NV, NY, PA, and SC.

    Quantity

    15 units