BEUDAMED
    FDA Enforcement Class II Terminated

    MOOG Curlin Infusion Administration Set, Ref 340-4134, Non-DEHP Microbore Tubing with Non-Vented Bag Spike and Y-Site with Check Valve, 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-0699-2018 · Reported March 7, 2018

    Enforcement

    Recall Number
    Z-0699-2018
    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 340-4134, Non-DEHP Microbore Tubing with Non-Vented Bag Spike and Y-Site with Check Valve, 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 38148440000495, Lot/serial numbers: CF1518304, CF1521104, CF1524301, CF1523803, CF1528603, and CF1613101.

    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

    2,497/20-administration set cases