BEUDAMED
    FDA Enforcement Class II Terminated

    MOOG Curlin Infusion Administration Set, Ref 340-4114, Non-DEHP Microbore Tubing with Non-Vented Bag Spike, packaged 20/box, for use with the MOOG Curlin Ambulatory Volumetric Infusion Pump, RX, Sterile. Product Usage: Administration set to be used with the Moog Curlin infusion Pump. The pump can be used for intravenous, intra-arterial, epidural, subcutaneous, or enteral infusions.

    Recall: Z-0697-2018 · Reported March 7, 2018

    Enforcement

    Recall Number
    Z-0697-2018
    Event ID
    78573
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Zevex Incorporated (dba Moog Medical Medical Devices Group)
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 7, 2018
    Initiation Date
    November 10, 2017
    Classification Date
    February 23, 2018
    Termination Date
    December 12, 2018
    Address
    4314 S Zevex Park Ln, N/A, Salt Lake City, UT, 84123-7881, United States

    Description

    MOOG Curlin Infusion Administration Set, Ref 340-4114, Non-DEHP Microbore Tubing with Non-Vented Bag Spike, packaged 20/box, for use with the MOOG Curlin Ambulatory Volumetric Infusion Pump, RX, Sterile. Product Usage: Administration set to be used with the Moog Curlin infusion Pump. The pump can be used for intravenous, intra-arterial, epidural, subcutaneous, or enteral infusions.

    Reason

    Particulate found on the Curlin spike.

    Code Info

    UDI 38148440000396, Lot/serial numbers: CF1514703, CF1514702, CF1514702, CF1514701, CF1514702, CF1517405, CF1517406, CF1518301, CF1518302, CF1518303, CF1518301, CF1521101, CF1521103, CF1521102, CF1521701, CF1522306, CF1522308, CF1522307, CF1523312, CF1524407, CF1524407, CF1525101, CF1524407, CF1525103, CF1525102, CF1526505, CF1526506, CF1527307, CF1527306, CF1528011, CF1528607, CF1528606, CF1529306, CF1529307, CF1530106, CF1530707, CF1530706, CF1530706, CF1530705, CF1530706, CF1530707, CF1530706, CF1530707, CF1532102, CF1531406, CF1532102, CF1531405, CF1532975, CF1532976, CF1532976, CF1532976, CF1532976, CF1535001, CF1533504, CF1534902, CF1535666, CF1600507, CF1600508, CF1601203, CF1601903, CF1602604, CF1603304, CF1604704, CF1605406, CF1606104, CF1607504, CF1610405, CF1611003, CF1612404, CF1613105, CF1613804, CF1615209, CF1616608, and CF1616608.

    Distribution

    Distribution was nationwide. There was government and military distribution. Foreign distribution was made to Canada, Saudi Arabia, Turkey, Croatia, United Arab Emirates, and Australia.

    Quantity

    56,244/20 administration set cases