Beasley, Allen, Crow, Methvin, Portis & Miles, P.C.

The Food and Drug Administration (FDA) has issued a Class I recall on select models of the Respironics, Inc., brand SmartMonitor 2 Infant Apnea Monitors because the device may fail to sound an alarm. A Class I recall is the most serious type of recall and involves situations in which there is reasonable probability that the use of the products will cause serious injury or death.

Included in the recall are Respironics, Inc. SmartMonitor 2 Infant Apnea Monitor models 4002 and 4002 with serial numbers 3000033364 through 3000038740. The recalled monitors were manufactured from January 16, 2008 through November 13, 2008 and distributed from January 17, 2008 through December 31, 2008.

The devices are used for the continuous monitoring of respiration and heart rate of infants in the home or in the hospital. The monitor detects and sounds an alarm for periods of temporary interruption of breathing (central apnea) or low heart rates. The specified monitor models were recalled because of reports that the devices may fail to sound an alarm.

The recall follows an April 23, 2009 letter from Respironics, Inc. to its medical supply companies informing them of the potential problems. The letter specified that all units in inventory be returned and for the suppliers to retrieve and return all units already shipped to patients.

Health care professionals and consumers may report adverse reactions or quality problems experienced with the use of these products to the FDA’s MedWatch Adverse Event Reporting program either online at www.fda.gov/MedWatch/report.htm, by regular mail or by FAX at 1-800-FDA-0178. For a postage-paid FDA form for regular mail, visit www.fda.gov/MedWatch/getforms.htm.

This entry was posted on Thursday, May 21st, 2009 at 7:16 am and is filed under product liability. You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response, or trackback from your own site.