Resuscitation systems used for the pulmonary resuscitation of infants are being recalled because of a defect that may cause the reversal of air/oxygen concentrations, which could lead to a life-threatening interruption of therapy. The recall is listed as a Class 1, which is the most serious type of recall issued by the Food and Drug Administration (FDA) and is reserved for products in which there is a reasonable probability that use will cause serious health consequences or death.
The recall affects certain models of the GE Healthcare T-Piece Resuscitation Systems and the Giraffe Panda Bag and Mask Resuscitation Systems, a device that provides the basic equipment required for pulmonary resuscitation of infants. Doctors and health care facilities have been notified of the recall and informed of corrective measures.
The recall comes just after GE Healthcare issued a recall of certain models of the GE Healthcare T-Piece Neonatal Patient Circuits for Giraffe and Panda Resuscitation Systems, with size 1 and size 0 masks. That recall was initiated because the disposable T-piece circuits do not achieve the maximum positive respiratory pressure levels needed for intense resuscitation. This failure to achieve desired inspiratory pressure during ventilation could result in inadequate therapy and the need for additional medical treatment. Results could be serious and life threatening.
Any adverse events caused by this or any other medical device should be reported to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.