Recall Z-1693-2009 ยท FMT Warmer, Infant Radiant
Draeger Medical Systems, Inc.
Heater Elements for Resuscitaire Infant Radiant Warmers model numbers RW82, RW82 VHA, WBR82, and WMRW82, 120 volt configuration only.
| Date | Aug 26, 2009 (initiated Jul 29, 2009) |
| Status | Terminated |
| Reason | 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. |
| Root 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 | 2915 elements |
| Distribution | Worldwide distribution: USA, Canada, Saudi Arabia, Bermuda, Virgin Islands, Mexico, Panama, Colombia, and Costa Rica. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K003335 | RESUSCITAIRE RADIANT WARMER; RESUSCITAIRE BIRTHING ROOM WARMER; RESUSCITAIR WALL MOUNTED RADIANT WARMER Hill-Rom Air-Shields, Nov 17, 2000 |