BEUDAMED
    FDA Recall Terminated

    King System , King LTSD Kit Size 4, non-sterile, REF KLTSD414, Manufacturer: King Systems Noblesville, IN. Ventilation during anesthesia during procedures of short duration. An oropharyngeal airway is a device inserted through the mouth to provide a patent airway.

    Recall: Z-1878-2011 · Initiated January 24, 2011

    Recall

    Recall Number
    Z-1878-2011
    Event Number
    57810
    Firm
    King Systems Corp.
    FEI Number
    1824226
    Product Code
    CAE
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 24, 2011
    Posted
    April 4, 2011
    Terminated
    June 29, 2012
    Address
    15011 Herriman Blvd, Noblesville, IN, 46060

    Description

    King System , King LTSD Kit Size 4, non-sterile, REF KLTSD414, Manufacturer: King Systems Noblesville, IN. Ventilation during anesthesia during procedures of short duration. An oropharyngeal airway is a device inserted through the mouth to provide a patent airway.

    Reason

    The firms contract manufacturer reported that the products were below the specification for hardness. This could contribute to a higher incidence of problems during the insertion and final positioning of the airway in the patient. In rare instances the softness of the tube could cause the tube to fold over.

    Action

    King Systems Corp. sent an URGENT DEVICE RECALL NOTICE letter dated January 24, 2011, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the customer. The letters instructed users to cease all sales of the recalled product, to notify the consignees for any product that was further distributed, and to return all recalled product to King Systems. The notice did include a response form. For questions call 317-776-6823, ext 257.

    Distribution

    Worldwide Distribution - USA and Canada

    Quantity

    138 cases 5 units per case, 690 units