FDA ALERT

 

August 26, 2009

Stabilet Infant Warmer models 200, 300, 1250, 1500, 200/3000, 2000, 2200/3200, 3000, and 3200 [Dräeger/Hill-Rom]

Audience: Pediatric and Obstetric Healthcare professionals, hospital risk managers

[UPDATED 08/25/2009; original alert 07/22/2009] FDA notified healthcare professionals of a Class 1 recall of these models of the Stabilet infant warmer because these out-of-date devices may cause serious injury to infants and caregivers due to the possibility that the warmer might be the ignition source for a fire. On July 20, 2009, Draeger sent a recall letter to all known customers, requested customers remove the affected devices from service, remove the heating element and the power cord to make the device unusable once removed from service and emphasized these devices are not to be used, donated or sold for any other purpose. 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.

Read the complete MedWatch 2009 Safety summmary including the July 22 alert and a link to the FDA recall notice and firm recall letter, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm173239.htm