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U.S. Department of Health and Human Services

Class 2 Device Recall Heater Elements for Resuscitaire Infant Radiant Warmers

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 Class 2 Recall
Heater Elements for Resuscitaire Infant Radiant Warmers
see related information
Date Posted August 26, 2009
Recall Status1 Terminated on October 13, 2010
Recall Number Z-1693-2009
Recall Event ID 52835
Premarket Notification
510(K) Number
K003335 
Product Classification Warmer, Infant Radiant - Product Code FMT
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
Manufacturer 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.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Process Control
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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = FMT and Original Applicant = HILL-ROM AIR-SHIELDS
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