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Medical device recalls for June 2012

Mon, 07/02/2012 - 1:54pm
Mass Device

Class I and class II recalls issued by the Center for Devices & Radiological Health in June 2012.

Class I recalls

Recalling Manufacturer, Date Posted, Trade Name/Product, Reason for Recall

Carefusion 2200 Inc                         Jun-29-2012                        AirLife Isothermal Breathing Circuit; Infant Respiratory Circuit; Non-Heated - AirLife Isothermal Breathing Circuit; Infant Respiratory Circuit; Non-Heated; an Rx device for single patient use; CareFusion; 22745 Savi Ranch Parkway; Yorba Linda; CA 92887 USA; Made in MexicoRespiratory breathing circuits are used with a ventilator when mechanical ventilation is administered to a patient.                          The Y adapter within the breathing circuit may spontaneously crack; causing a leak in the closed ventilation system.  This leak could lead to a decrease in the tidal volume delivered to the ventilated patient.  

Carefusion 2200 Inc                         Jun-29-2012                        AirLife Isothermal Breathing Circuit; Infant Respiratory Circuit; Heated - AirLife Isothermal Breathing Circuit; Infant Respiratory Circuit; Heated; an Rx device for single patient use; CareFusion; 22745 Savi Ranch Parkway; Yorba Linda; CA 92887 USA; Made in MexicoRespiratory breathing circuits are used with a ventilator when mechanical ventilation is administered to a patient.                          The Y adapter within the breathing circuit may spontaneously crack; causing a leak in the closed ventilation system.  This leak could lead to a decrease in the tidal volume delivered to the ventilated patient.                                              

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