BEUDAMED
    FDA Recall Terminated

    KING LAD SILI CONE SINGLE USE, King Systems, 10 devices/case, ETO Sterile Size 5 / Adult Silicone King LAD Patient Size: >70kg Product Usage: Laryngeal airway

    Recall: Z-0421-2013 · Initiated November 2, 2012

    Recall

    Recall Number
    Z-0421-2013
    Event Number
    63580
    Firm
    King Systems Corp.
    FEI Number
    1824226
    Product Code
    CAE
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    November 2, 2012
    Posted
    November 21, 2012
    Terminated
    May 28, 2013
    Address
    15011 Herriman Blvd, Noblesville, IN, 46060

    Description

    KING LAD SILI CONE SINGLE USE, King Systems, 10 devices/case, ETO Sterile Size 5 / Adult Silicone King LAD Patient Size: >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

    Action

    King Systems sent an URGENT MEDICAL DEVICE RECALL NOTIFICATION letter dated October 31, 2012 to all affected consignees via email. The letter identified affected product, problem and actions to be taken. The letter states that further use and/or distribution of any remaining product affected by this recall should cease immediately. The letter instructs customers to destroy all of the affected products and indicate the destruction by signing and returning the attached forms using the enclosed self-addressed envelope. For questions contact your King Systems customer service representative at 800-642-5464.

    Distribution

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

    Quantity

    263 cases of product. (2,630 devices)