GE Healthcare, LLC, Giraffe and Panda T-Piece Resuscitation Systems and Mask Resuscitation Systems: Class 1 Recall
MedSun: Newsletter #82, March 2013

FDA MedWatch Safety Alert

The oxygen and air wall inlet fittings and/or labels on the back panel of the resuscitation systems may have been reversed during assembly. As a result, this could potentially reverse the air/oxygen concentrations; for example, a setting of 100% oxygen could have an output of 21% oxygen and vice versa. The settings of the blender knob would no longer be accurate.

Additional Information:

GE Healthcare, LLC, Giraffe and Panda T-Piece Resuscitation Systems and Mask Resuscitation Systems: Class 1 Recall. February 14, 2013
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm339884.htm


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