BEUDAMED
    FDA Enforcement Class II Terminated

    Vital Signs Anesthesia Circuits The Ventilator Circuit is intended for use as an interface between a ventilator dependent patient and a ventilator. The Anesthesia Circuit is intended to administer medical gases to a patient during anesthesia. The CPAP Circuit is intended to increase the airway pressure of a patient.

    Recall: Z-0812-2014 · Reported January 29, 2014

    Enforcement

    Recall Number
    Z-0812-2014
    Event ID
    67164
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Vital Signs Colorado Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 29, 2014
    Initiation Date
    December 26, 2013
    Classification Date
    January 23, 2014
    Termination Date
    July 9, 2014
    Address
    11039 East Lansing Circle, Englewood, CO, 80112-5909, United States

    Description

    Vital Signs Anesthesia Circuits The Ventilator Circuit is intended for use as an interface between a ventilator dependent patient and a ventilator. The Anesthesia Circuit is intended to administer medical gases to a patient during anesthesia. The CPAP Circuit is intended to increase the airway pressure of a patient.

    Reason

    A circuit in use was occluded by a blue port cap that was inadvertently attached to the circuit as a result of an internal inspection error and will cause occlusion of gas flow.

    Code Info

    PartNumber : 4S78XX00,155512,155518,156505,156545,1576162,1576214,542011,542021,542031,1553196,1572347,1553402,156205,156310,1574701,1574710,1574711,1574712,1574723,1572414,A4JXXXXX,6463,C311123X,C6X1XX1X,207002,C316123X,1560023,201814,1730327,20CF800C,C116123X,1570103,20CT8050,1577112,1552016,A4JXOXXX,CXX61X2X,1552017,1552018,20CT8048,20CT8055,M1171508,M1181639,1552020,M1162025,155200EU,1552017CN,1574792,M1171508VS,M1181639VS,1552026,1552027,1552028,

    Distribution

    Worldwide Distribution - USA (nationwide) including Puerto Rico; and Internationally to: Belgium, Canada, Chile, Mexico, Costa Rica, Kuwait, United Kingdom, Greece, Czech Republic, Latvia, Turkey, China, France, Italy, Brazil, Korea, Germany, Thailand, Egypt, Austria, Dominican Republic, India, Israel, Colombia, Japan, Netherlands, Venezula, Saudi Arabia, Argentina, Malaysia, Sweden, Lebanon, South Korea, Finland, United Arab Emirates, Taiwan, Panama, Uruguay, Singapore, Hong Kong, Ecuador, Peru, Oman, Spain, Lithuania, and South Africa.

    Quantity

    1,827,920 units US , 504,760 units OUS