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    Avance Flex 2.0 Negative Pressure Wound Therapy Pump

    FDA UDI
    APRIA HEALTHCARE LLC·00860385000855·Avance Flex Pump

    Avance Flex Negative Pressure Wound Therapy Canister, 300ML

    FDA UDI
    APRIA HEALTHCARE LLC·00860385000824·300ml Avance Flex Canister for use with the Ava...

    Viterion 100-BGM TeleHealth Monitor, Model No. 09377512, Product Code/Part No. 81842478, Bayer HealthCare LLC 555 White Plains Road, Tarrytown, NY 10591-5097 USA --- Manufactured in Japan for Bayer HealthCare LLC -- Common Name: Viterion100 TeleHealth Monitor -- Classification Name: Monitor, Physiological, Patient (Without Arrhythmia Detection or Alarms) [ref. 21CFR 870.2300] Product Usage: The Viterion 100 TeleHealth Monitor and related Data Server are physiological monitoring systems. The systems collect, accumulate and periodically transmit patient vital signs and other physiological data from a patient who may be remote from the healthcare practitioner to the practitioner, and provides communication between the patient and the practitioner. The physiological monitoring instrument, selected by the healthcare practitioner, operates in conjunction with the Patient Terminal located in the patients home, a hospital room, nursing home, or other healthcare facility. The Patient Terminal connects to the server via a conventional or cellular telephone line. The system is not a real-time monitoring system, and there is no requirement that a health care professional review the information at any specific interval or provide immediate feedback to patients. Rather, the system is intended to aid the physicians longer term management of patients. Patients are expected to take the same short term actions in response to physiological data as they ordinarily would in the absence of the Tele Health Monitor.

    FDA Recall
    Terminated ·Viterion TeleHealthcare Llc·Product code MWI·May 25, 2011

    Material DT9345E, DRESSING CHANGE TRAY, CENTURION, STRATEGIC HEALTHCARE SOLUTIONS LLC. DRESSING CHANGE TRAY, REORDER DT9345E, STERILE, LATEX FREE, CENTURION MEDICAL PRODUCTS CORP. WILLIAMSTON MI 48895, USA 800.248.4058 www.centurionmp.com FACILITATES DRESSING CHANGE

    FDA Recall
    Terminated ·Centurion Medical Products Corporation·Product code MCY·March 31, 2011