Heater Elements for Resuscitaire Infant Radiant Warmers model numbers RW82, RW82 VHA, WBR82, and WMRW82, 120 volt config
FDA device recall Z-1693-2009 · posted 2009-08-26 · Terminated
Recall details
- Recalling firm
- Draeger Medical Systems, Inc.
- 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 taken
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- FMT
- Quantity affected
- 2915 elements
- Distribution
- Worldwide distribution: USA, Canada, Saudi Arabia, Bermuda, Virgin Islands, Mexico, Panama, Colombia, and Costa Rica.
- Date initiated
- 2009-07-29
- Date posted
- 2009-08-26
- Date terminated
- 2010-10-13
- Location
- Telford, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| RESUSCITAIRE RADIANT WARMER; RESUSCITAIRE BIRTHING ROOM WARMER; RESUSCITAIR WALL MOUNTED RADIANT WARMER (K003335) | Hill-Rom Air-Shields | 2000-11-17 |