Respironics Baby Monitor Recall

The Food and Drug and Administration announced a Class-I recall of Respironics SmartMonitor 2 infant apnea monitors because of defects that could cause malfunctioning.

Respironics Baby Monitor RecallThe recall affects monitor models 4002 and 4003, and serial numbers from 30000333364 through 3000038740 (note: if you have a monitor outside of this range, the firm is evaluating such cases too). The devices were manufactured from January 16, 2008 to November 13, 2008, and were distributed between January and December 2008. The Respironics infant apnea monitor is used to monitor the breathing and heart rates of infants who suffer from sleep apnea. It detects periods of temporary interruption in breathing and sounds an alarm warning caregivers. It also detects low heart rates. The monitor can be used in the home or at the hospital.

According to the FDA alert, the device may malfunction and fail to sound an alarm during any interruption in breathing or drop in the heart rate. In April 2009, Respironics Inc., the company that manufactures the sleep apnea monitors, sent out a letter to medical supply dealers, warning them of the defect. All dealers were asked to return monitors in their inventory and retrieve monitors that had already been shipped to patients. The FDA classified this as a Class-I recall, which is the most serious. A Class-I recall is issued when the agency believes that there is "reasonable probability" that using a product will result in serious injuries or death.

Healthcare professionals and caregivers have been advised to report any adverse reactions with the use of the sleep apnea monitors to the agency's MedWatch Adverse Event Reporting Program.

Infant Sleep Apnea

Infant sleep apnea is a baby sleep disorder, in which the baby stops breathing during sleep for 20 seconds or more. The condition is more common in premature babies, and is likely to be seen in children below the age of one. Symptoms of sleep Apnea include:

  • Snoring
  • Disturbed sleep
  • Breathing through the mouth
  • Inattention while awake

Babies who have sleep apnea may suffer from lower intake of oxygen. Such lack of oxygen could have a negative impact on their health.

Our lawyers are evaluating these Respironics Apnea Monitor cases. Contact us for a fee evaluation.

Client Reviews
"I, along with dad and family, want to thank your law firm for all that you did for us in representing my dad in his case. We were very satisfied with the settlement and the overall efforts by your firm. We also think that you and your staff made the process seem calm and smooth, yet professional. We could not have asked for a better attorney -- we would recommend you and your firm to anyone needing your expertise. Thanks so much for everything!!!" D. Hayes and C. Griffin, Clay County, AL
"Mr. Clay, I want to express my gratitude to you for agreeing to take my case. I know that I contacted your law firm with a fast approaching statute of limitations and some really significant challenges in proving my case. Thanks for the time, work, research and energy that you put into my case and for helping achieve a successful outcome. Peace and blessings to you and your family." V. Daniel, Philadelphia, PA
"The team at Hollis Wright were there for my husband when no one else would take his case. Not only did he work hard and recover money that we were owed. Without the help of Hollis Wright, we couldn't have afforded the care my husband needed and I would have lost him much sooner. We'll always consider you a part of the family." Donna B. Jemison, AL