FDA Device

Heater Elements for Resuscitaire Infant Radiant Warmers model numbers RW82, RW82 VHA, WBR82, and WMRW82, 120 volt configuration only.

Hazard

Spark, flame and smoke: A mis-positioned crimp on heater element lead wire resulted in flame and smoke aerating from the top of the warmer assembly.

What You Should Do

Remedy

Draeger Medical issued an Urgent Medical Device Recall letter via certified mail on 8/7/09. The letter explained the problem, the need to conduct an inspection of the infant warmer (instructions included), and request replacement elements.

Products

Heater Elements for Resuscitaire Infant Radiant Warmers model numbers RW82, RW82 VHA, WBR82, and WMRW82, 120 volt configuration only.
Brand
Draeger Medical Systems, Inc.
UPC
Model numbers RW82, RW82 VHA, WBR82, and WMRW82. Date codes ending in 07

Units Affected

2915 elements