2 results
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19ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Pulmonetic Systems P/N 19189-001 Patient Circuit SPU W/O PEEP 15 FT 5/Pkg. These circuits are intended for use with the MR Conditional LTV 1200 System with the ventilator utilizing an external exhalation valve, as single patient use (SPU) only patient circuits for adult and pediatric patients. The LTV 1200 ventilator is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. The ventilator is suitable for use in institutional, home and transport settings, and is applicable for adult and pediatric patients weighing at least 5 kg (11 lbs.), who require the following types of ventilatory support: -Positive Pressure Ventilation, delivered invasively (via ET tube) or non-invasively (via mask). -Assist/Control, SIMV, CPAP or NPPV modes of ventilation. -Breath types including Volume, Pressure Control and Pressure Support.
FDA Recall
Terminated
·Product code CBK·July 2, 2010
CareFusion EnVe and ReVel Ventilators. The EnVe/ ReVel Ventilator is designed for use on patients who require respiratory support or mechanical ventilation and weigh a minimum of 5 kg (11 lbs.). It is suitable for service in hospital, transport and homecare as a source of continuous or intermittent positive pressure ventilator support, delivered invasively or non-invasively. These ventilators are restricted medical devices intended for operation by a trained personnel under the direction of a physician and in accordance with all applicable state laws and regulations.
FDA Recall
Terminated
·Product code CBK·August 8, 2014