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U.S. Department of Health and Human Services

Medical & Radiation Emitting Device Recalls
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 Class 2 Recall
Heater Elements for Resuscitaire Infant Radiant Warmers		see related information
Date Posted August 26, 2009
Recall Number Z-1693-2009
Product Heater Elements for Resuscitaire Infant Radiant Warmers model numbers RW82, RW82 VHA, WBR82, and WMRW82, 120 volt configuration only.
Code Information Model numbers RW82, RW82 VHA, WBR82, and WMRW82. Date codes ending in 07
Recalling Firm/
Manufacturer		 Draeger Medical Systems, Inc.
3135 Quarry Rd
Telford, Pennsylvania 18969-1042
For Additional Information Contact Bryan Overton
800-543-5047
Reason for
Recall		 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.
Action 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.
Quantity in Commerce 2915 elements
Distribution Worldwide distribution: USA, Canada, Saudi Arabia, Bermuda, Virgin Islands, Mexico, Panama, Colombia, and Costa Rica.
 
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