BEUDAMED
    FDA Recall Terminated

    King Systems Universal Flex2 Breathing Circuit, Latex Free, 50 per case, King Systems Corporation, Noblesville, IN; REF # DF470-60Z. This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation.

    Recall: Z-0733-2009 · Initiated August 1, 2008

    Recall

    Recall Number
    Z-0733-2009
    Event Number
    48991
    Firm
    King Systems Corp.
    FEI Number
    1824226
    Product Code
    CAI
    Status
    Terminated
    Root Cause
    Pending
    Initiated
    August 1, 2008
    Posted
    February 3, 2009
    Terminated
    November 12, 2009
    Address
    15011 Herriman Blvd, Noblesville, IN, 46060

    Description

    King Systems Universal Flex2 Breathing Circuit, Latex Free, 50 per case, King Systems Corporation, Noblesville, IN; REF # DF470-60Z. This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation.

    Reason

    The inner line may be severed or broken into two pieces, thus hindering the delivery of oxygen and anesthetics to the patient and possibly elevated patient carbon dioxide levels.

    Action

    Consignees were notified by an Urgent Product Recall letter on or about 7/29/2008 to cease sales, notify their customers to the hospital level, and to return product on hand.

    Distribution

    Worldwide Distribution - including USA and countries of Australia, Colombia, Germany, Netherlands, and Peru.

    Quantity

    Approx. 500,000 units of all products.