BEUDAMED
    FDA Recall Terminated

    KING LTS -D, Size 5, 10-0027, Oropharyngeal Airway. King Systems Corporation 15011 Herriman Boulevard, Noblesville, IN 46060. Intended use: Airway management by providing a patent airway to allow patient ventilation.

    Recall: Z-0979-2011 · Initiated December 15, 2009

    Recall

    Recall Number
    Z-0979-2011
    Event Number
    54350
    Firm
    King Systems Corp.
    FEI Number
    1824226
    Product Code
    CAE
    Status
    Terminated
    Root Cause
    Labeling False and Misleading
    Initiated
    December 15, 2009
    Posted
    January 27, 2011
    Terminated
    August 16, 2012
    Address
    15011 Herriman Blvd, Noblesville, IN, 46060

    Description

    KING LTS -D, Size 5, 10-0027, Oropharyngeal Airway. King Systems Corporation 15011 Herriman Boulevard, Noblesville, IN 46060. Intended use: Airway management by providing a patent airway to allow patient ventilation.

    Reason

    King Systems was issued a warning letter from the Center for Devices and Radiological Health, Office of Compliance on October 28, 2009. The warning letter asserts that Kings Systems KLT(S)-D airway exceeds cleared indications in that it is promoted for "airway management in patients over 4 feet in height, for controlled or spontaneous ventilation, difficult and emergent airway cases, and ambulat

    Action

    On October 29, 2009, the firm, Kings System, sent a "Urgent - Product Correction" letter to the customers. The letter described the product, problem and actions to be taken. The customers were instructed to remove the promotional material from the King System website which includes literature, and Instructions for Use. The firm instructed all Sales force and distributors to cease dissemination of promotional materials, literature and communications. Note: The firm revised indications, instructions for use, product labels and labeling so it is aligned with the 510Ks. The customers were also instructed to replace current instructions for use with revised instructions for use and destroy the current IFU; return Kings LT(S)-D oropharyngeal airway product inventory to King Systems; and complete and return the attached Instructions for Use Destruction Signature Form via fax to King Systems at 317-776-5197. For further information, please call 317-776-6823 ext 257 or email: [email protected].

    Distribution

    Worldwide distribution: USA and countries including: Canada, Costa Rica, and Panama.

    Quantity

    25,000 all products