BEUDAMED
    FDA Enforcement Class I Terminated

    Universal Flex2 Breathing Circuit Class I 510(k) Exempt An anesthesia breathing circuit is a device that is intended to administer medical gases to a patient during anesthesia. It provides both an inhalation and exhalation route and may include a connector, adaptor, and Y-piece.

    Recall: Z-2272-2013 · Reported October 9, 2013

    Enforcement

    Recall Number
    Z-2272-2013
    Event ID
    66184
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    King Systems Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 9, 2013
    Initiation Date
    August 23, 2012
    Classification Date
    September 27, 2013
    Termination Date
    November 18, 2013
    Address
    15011 Herriman Blvd, Noblesville, IN, 46060-4253, United States

    Description

    Universal Flex2 Breathing Circuit Class I 510(k) Exempt An anesthesia breathing circuit is a device that is intended to administer medical gases to a patient during anesthesia. It provides both an inhalation and exhalation route and may include a connector, adaptor, and Y-piece.

    Reason

    King Systems received a customer complaint indicating that the customer had ordered a breathing circuit with a Latex breathing bag. The product they received contained a Latex breathing bag, but was labeled as non-latex.

    Code Info

    Part Number DF4110-61 Lot Number I063N

    Distribution

    Nationwide Distribution - NE only.

    Quantity

    1 case; 40 units