Resuscitation systems used for the pulmonary resuscitation of infants are being recalled because of a defect that causes them not to provide adequate resuscitation during ventilation. This recall is classified as a Class 1, the most serious type of recall the Food and Drug Administration (FDA) gives and is reserved for products in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
The recall affects certain models of the GE Healthcare T-Piece Neonatal Patient Circuits for Giraffe and Panda Resuscitation Systems, with size 1 and size 0 masks. The recall was initiated because the disposable T-piece circuits do not achieve the maximum positive inspiratory pressure (PIP) levels of 45+/-cmH2O needed for intense resuscitation. This failure to achieve the desired inspiratory pressure during ventilation may result in inadequate therapy, and the need for additional medical intervention. Results could be serious and life threatening.
Health care professionals have been contacted and notified of the defect and told not to use a T-piece patient circuit that does not reach the maximum PIP level of 45+/-cmH@O and always use the built-in Airway Pressure Manometer to verify the PIP value. Medical professionals were also urged to continue to emphasize the recommended pre0use checkout practices with this device.
Any adverse reactions or quality problems with this or any other medical device should be reported to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.