The U.S. Food and Drug Administration has announced a class I recall of the Respironics SmartMonitor 2 Infant Apnea Monitor,1 models 4002 and 2003 (Respironics, Murryville, PA). The SmartMonitor 2 is often used for home monitoring of infants at risk for apnea or bradycardia. Monitors manufactured from January 16, 2008, through November 13, 2008, with serial numbers 3000033364 through 3000038740 are affected.

The recall was issued because the monitors may "fail to sound an alarm during periods of temporary interruption of breathing or low heart rates."2 Medical supply companies have been requested to return all units in their inventory and to retrieve and return all units already shipped to patients.

Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious injury or death. Adverse events associated with the SmartMonitor 2 Infant Apnea Monitor should be reported to the Food and Drug Administration's MedWatch reporting program by telephone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, or online at http://www.fda.gov/Safety/MedWatch/default.htm.

References