BEUDAMED
    FDA Enforcement Class II Ongoing

    ExactaMix, Model: H938901, EMPTY EVA DUAL CHAMBER CONTAINER With Screw Connectors, 500 ml/ 2500 ml, Baxter - Product Usage: For use in an intravenous admixture program. The empty container will be filled with parenteral admixtures under normal pharmacy conditions, e.g. laminar flow hood. The use of this product is for storage and delivery of intravenous parenteral admixtures.

    Recall: Z-0007-2020 · Reported October 9, 2019

    Enforcement

    Recall Number
    Z-0007-2020
    Event ID
    83509
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    The Metrix Company
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    October 9, 2019
    Initiation Date
    September 21, 2018
    Classification Date
    October 1, 2019
    Address
    4400 Chavenelle Rd, N/A, Dubuque, IA, 52002-2655, United States

    Description

    ExactaMix, Model: H938901, EMPTY EVA DUAL CHAMBER CONTAINER With Screw Connectors, 500 ml/ 2500 ml, Baxter - Product Usage: For use in an intravenous admixture program. The empty container will be filled with parenteral admixtures under normal pharmacy conditions, e.g. laminar flow hood. The use of this product is for storage and delivery of intravenous parenteral admixtures.

    Reason

    Potential for leaking product

    Code Info

    Lot Numbers: H938901 63615-A1768, H938901 63615-A1770, H938901 63615-A1772, H938901 63615-A2648, H938901 63615-A2650, H938901 63615-A2652, H938901 63615-A2653, H938901 63615-A2654, H938901 63615-A2656, H938901 63615-A2658, H938901 63615-A2660, H938901 63615-A2662, H938901 63615-A3951, H938901 63615- A3953, H938901 63615-A3955, H938901 63615-A3958, H938901 63615-A3960, H938901 63615-A3962, H938901 63615-A3964, H938901 63615-A3966, H938901 63615-A3967, H938901 63615-A5337, H938901 63615-A5339, H938901 63615-A5341, H938901 63615-A5343, H938901 63615-A5345, H938901 63615-A5347, H938901 63615-A5349

    Distribution

    US Nationwide distribution including the states of PA, MA, IL CA.

    Quantity

    175392 bags