BEUDAMED
    FDA Enforcement Class II Terminated

    ColorSafe IV lines Catalog No.(Model No.) CS3000-R (76.7806), CS400-R (76.7800), CS408N-R (76.8000), CS3000-B (76.7807), B314 (25.7406), CS400-B (76.7801), CS408N-B (76.8001), CS3000-O (76.7808), CS400-O (76.7802), CS408N-O (76.8002), CS3000-G (76.7809), CS400-G (76.7803), CS408N-G (76.8004), CS3000-P (76.7810), CS400-P (76.7804), CS408N-P (76.8003). Intravenous administration sets

    Recall: Z-2040-2014 · Reported July 16, 2014

    Enforcement

    Recall Number
    Z-2040-2014
    Event ID
    68591
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Codan Us Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 16, 2014
    Initiation Date
    August 17, 2011
    Classification Date
    July 10, 2014
    Termination Date
    July 10, 2014
    Address
    3511 W Sunflower Ave, Santa Ana, CA, 92704-6944, United States

    Description

    ColorSafe IV lines Catalog No.(Model No.) CS3000-R (76.7806), CS400-R (76.7800), CS408N-R (76.8000), CS3000-B (76.7807), B314 (25.7406), CS400-B (76.7801), CS408N-B (76.8001), CS3000-O (76.7808), CS400-O (76.7802), CS408N-O (76.8002), CS3000-G (76.7809), CS400-G (76.7803), CS408N-G (76.8004), CS3000-P (76.7810), CS400-P (76.7804), CS408N-P (76.8003). Intravenous administration sets

    Reason

    CODAN US Corporation is recalling the ColorSafe IV (intravenous) product lines because they were manufactured and marketed prior to FDA approval.

    Code Info

    Lot No. 71701, 90391, 71716, 90386, 72155, 71704, 90392, 72473, 72398, 72561, 72934, 90387, 72156, 71707, 90393, 72564, 90388, 72157, 71710, 90394, 71719, 90389, 72159, 71713, 90395, 71720, 90390, 72158.

    Distribution

    Worldwide Distribution - US including TX, CT, NY and Internationally to Belgium.

    Quantity

    7250 units