BEUDAMED
    FDA Enforcement Class I Terminated

    98" (249 cm) Appx 12.3 ml, 60 Drop Primary Set w/Pre-Slit Port, STAT 2 Flow Controller, Rotating Luer, Item No. Z2648. Product Usage: IV Administration sets are intended for the infusion and withdrawal of fluids. The devices are provided sterile.

    Recall: Z-2622-2014 · Reported October 1, 2014

    Enforcement

    Recall Number
    Z-2622-2014
    Event ID
    69088
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    ICU Medical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 1, 2014
    Initiation Date
    August 19, 2014
    Classification Date
    September 19, 2014
    Termination Date
    November 18, 2014
    Address
    951 Calle Amanecer, N/A, San Clemente, CA, 92673-6212, United States

    Description

    98" (249 cm) Appx 12.3 ml, 60 Drop Primary Set w/Pre-Slit Port, STAT 2 Flow Controller, Rotating Luer, Item No. Z2648. Product Usage: IV Administration sets are intended for the infusion and withdrawal of fluids. The devices are provided sterile.

    Reason

    ICU is recalling the ConMed Stat 2 flow controller because it may deliver a significantly higher flow rate than was intended.

    Code Info

    Lot # 34-128-HE, 34-540-Y1, 35-151-SJ, 35-805-JW, 36-137-SL, 36-469-SL

    Distribution

    Worldwide Distribution - US (nationwide) in the state of WA, OR and the country of South Africa.

    Quantity

    1150 units