Class 2 Device Recall Heater Elements for Resuscitaire Infant Radiant Warmers

• Date Initiated by Firm: July 29, 2009
• Date Posted: August 26, 2009
• Recall Status: Terminated on October 13, 2010
• Recall Number: Z-1693-2009
• Recall Event ID: 52835
• 510(K)Number: K003335
• Product Classification: Heater Element for Infant Radiant Warmer - 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 PA 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: 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 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = FMT