BEUDAMED
    FDA Enforcement Class II Terminated

    MOOG Curlin Infusion Administration Set, REF 340-4130-V, Non-DEHP Tubing with Non-Vented Bag Spike and Vented 0.2 Micron Filter with add-on check valve, packaged 20 sets/carton, sterile. The firm name on the label is ZEVEX, Inc., Salt Lake City, UT.

    Recall: Z-2054-2019 · Reported July 31, 2019

    Enforcement

    Recall Number
    Z-2054-2019
    Event ID
    82864
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Zevex Incorporated (dba MOOG Medical Devices Group)
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 31, 2019
    Initiation Date
    February 27, 2019
    Classification Date
    July 23, 2019
    Termination Date
    April 28, 2021
    Address
    4314 S Zevex Park Ln, N/A, Salt Lake City, UT, 84123-7881, United States

    Description

    MOOG Curlin Infusion Administration Set, REF 340-4130-V, Non-DEHP Tubing with Non-Vented Bag Spike and Vented 0.2 Micron Filter with add-on check valve, packaged 20 sets/carton, sterile. The firm name on the label is ZEVEX, Inc., Salt Lake City, UT.

    Reason

    Administration sets leaked at the filter.

    Code Info

    Lot numbers CF1820216, CF1821617, CF1822214, and CF1823616, UDI 38148440000471.

    Distribution

    Distribution was made to GA, IL, KS, MA, MI, and OH. There was no foreign/military/government distribution.

    Quantity

    756/20-set cases