BEUDAMED
    FDA Enforcement Class II Terminated

    KING LAD Flexible ClearSeal SINGLE USE, King Systems ETO Sterilie, 10 devices/case "Size 4 / Adult ClearSeal Flexible King LAD¿ Patient Size: 50-70kg " Product Usage: Laryngeal airway

    Recall: Z-0427-2013 · Reported November 28, 2012

    Enforcement

    Recall Number
    Z-0427-2013
    Event ID
    63580
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    King Systems Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    November 28, 2012
    Initiation Date
    November 2, 2012
    Classification Date
    November 21, 2012
    Termination Date
    May 28, 2013
    Address
    15011 Herriman Blvd, N/A, Noblesville, IN, 46060, United States

    Description

    KING LAD Flexible ClearSeal SINGLE USE, King Systems ETO Sterilie, 10 devices/case "Size 4 / Adult ClearSeal Flexible King LAD¿ Patient Size: 50-70kg " Product Usage: Laryngeal airway

    Reason

    The firm received two complaints from a user facility in New Jersey regarding color-coded EtO sterilization indicators on the primary device packaging that did not undergo the expected color change. The complainant reported devices that had pink color indicators when the product packaging specified that the color should change from pink to yellow (or brown) if the product had subjected to an EtO

    Code Info

    REF: LAD-904, Lot #K120417

    Distribution

    US Nationwide Distribution - WI, TX, NY, MO, IN, KY, FL, NJ, PA, TN, and NC

    Quantity

    263 cases of product. (2,630 devices)